Trial · NCT01609556
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors
NCT01609556, Phase 1, Completed, ImmunoGen, Inc.; results first posted 2021-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors. Trials, record NCT01609556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01609556
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors
- NCT number
- NCT01609556
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 206 participants, actual
- Lead sponsor
- ImmunoGen, Inc.
- Conditions
- Tumors
- Interventions
- Mirvetuximab soravtansine
- First posted
- 2012-06-01
- Last updated
- 2021-02-17
- Results first posted
- 2021-02-17
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-Escalation Phase: Maximum Tolerated Dose (MTD) of Mirvetuximab Soravtansine | Cycle 1 (21 days) | MTD was defined as the highest dose at which 1 or fewer among 6 participants or less than or equal to (\<=) 33 percent (%) experienced a dose-limiting toxicity (DLT) (calculated based on adjusted ideal body weight \[AIBW\]). AIBW was calculated as ideal body weight (IBW) + 0.4 \* (actual weight - IBW), where IBW for men was 0.9 \* height in centimeters (cm) - 88 and IBW for women was 0.9 \* height in cm - 92. DLT was defined as a treatment-emergent adverse event (TEAE) or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. |
| Primary | Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of Mirvetuximab Soravtansine | Cycle 1 (21 days) | RP2D was determined by MTD. MTD was defined as the highest dose at which 1 or fewer among 6 participants or \<=33% experienced a DLT. DLT was defined as a TEAE or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. Available clinical data indicated that the MTD defined for the Q3W schedule was equal to the RP2D. |
| Secondary | Number of Participants With TEAEs | From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC) | An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 on following scale: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose. |
| Secondary | Number of Participants With Shift From Baseline Grade <=2 in Clinical Laboratory Parameters to Grade 3 or Grade 4 on Study | From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC) | Laboratory parameters included serum chemistry (alanine aminotransferase \[ALT\]/serum glutamic pyruvic transaminase \[SGPT\], aspartate aminotransferase \[AST\]/serum glutamic oxaloacetic transaminase \[SGOT\], albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, magnesium, phosphorous, potassium, sodium), hematology (hemoglobin, lymphocytes, neutrophils, platelets, white blood cells) and coagulation (international normalized ratio \[INR\], partial thromboplastin time \[PTT\]). Clinically significant laboratory values were defined as per NCI CTCAE v.03 Grade 3 or higher. A grading (severity) scale was provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Only participants who shifted from a baseline value of Grade \<=2 to a post-baseline Grade 3/4 on-treatment, are reported. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings and Vital Signs | From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC) | Physical examination included assessments of general appearance, skin, head (eyes, ears, nose, and throat), neck, lungs, heart, abdomen, back, lymph nodes, extremities, and neurological system. Vital signs included assessment of blood pressure, pulse rate, respiratory rate and body temperature. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | Baseline up to end of treatment (EOT) (up to maximum 124 weeks) | Standard ECGs were performed in triplicate at 2- to 5-minute intervals during the study. A single ECG was performed at the end of treatment visit and as clinically indicated. |
| Secondary | Number of Participants With Treatment-Emergent Ocular AEs | From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC) | Ocular AEs included keratopathy and blurred vision. An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D | Cycle 1, 3: Day 1 (pre-infusion; within 10 minutes [min] of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion) | Pharmacokinetic (PK) parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3. |
| Secondary | Cmax of Free DM4 and S-Methyl DM4 at RP2D | Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion) | PK parameters were calculated using standard non-compartmental methods. PK analysis of free N2'-\[4-\[(3-carboxypropyl)dithio\]-4-methyl-1-oxo-2-sulfopentyl\]-N2'-deacetylmaytansine (DM4) and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3. |
| Secondary | Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D | Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion) | PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-Escalation Phase: Maximum Tolerated Dose (MTD) of Mirvetuximab Soravtansine | Cycle 1 (21 days) | Safety population included all participants who were enrolled and received at least 1 dose of study drug. | mg/kg | NUMBER |
| PRIMARY | Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of Mirvetuximab Soravtansine | Cycle 1 (21 days) | Safety population included all participants who were enrolled and received at least 1 dose of study drug. | mg/kg | NUMBER |
| SECONDARY | Number of Participants With TEAEs | From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC) | Safety population included all participants who were enrolled and received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline Grade <=2 in Clinical Laboratory Parameters to Grade 3 or Grade 4 on Study | From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC) | Safety population included all participants who were enrolled and received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings and Vital Signs | From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC) | Safety population included all participants who were enrolled and received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | Baseline up to end of treatment (EOT) (up to maximum 124 weeks) | Safety population included all participants who were enrolled and received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Ocular AEs | From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC) | Safety population included all participants who were enrolled and received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D | Cycle 1, 3: Day 1 (pre-infusion; within 10 minutes [min] of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion) | PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories. | micrograms per milliliter (mcg/mL) | MEAN |
| SECONDARY | Cmax of Free DM4 and S-Methyl DM4 at RP2D | Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion) | PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories. | nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D | Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion) | PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories. | hours*milligrams/milliliter (hr*mg/mL) | MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group283
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-Escalation Phase: Maximum Tolerated Dose (MTD) of Mirvetuximab Soravtansine | Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W) | 6.0 | mg/kg | ||
| Dose-Escalation Phase: Maximum Tolerated Dose (MTD) of Mirvetuximab Soravtansine | Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly) | 2.0 | mg/kg | ||
| Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of Mirvetuximab Soravtansine | Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W) | 6.0 | mg/kg | ||
| Number of Participants With TEAEs | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) | Any TEAE | 2 | Participants | |
| Number of Participants With TEAEs | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) | Any TEAE | 1 | Participants | |
| Number of Participants With TEAEs | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) | Any TEAE | 0 | Participants | |
| Number of Participants With TEAEs | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) | Any TEAE | 1 | Participants | |
| Number of Participants With TEAEs | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) | Any TEAE | 9 | Participants | |
| Number of Participants With TEAEs | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) | Any TEAE | 18 | Participants | |
| Number of Participants With TEAEs | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) | Any TEAE | 7 | Participants |
1 to 10 of 283Source ClinicalTrials.gov
See all 283 results by groupParticipant flow112
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation: Maximum 101.3 Weeks | STARTED | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) | 2 | |
| Dose Escalation: Maximum 101.3 Weeks | STARTED | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) | 1 | |
| Dose Escalation: Maximum 101.3 Weeks | STARTED | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) | 1 | |
| Dose Escalation: Maximum 101.3 Weeks | STARTED | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) | 1 | |
| Dose Escalation: Maximum 101.3 Weeks | STARTED | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) | 9 | |
| Dose Escalation: Maximum 101.3 Weeks | STARTED | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) | 18 | |
| Dose Escalation: Maximum 101.3 Weeks | STARTED | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) | 7 | |
| Dose Escalation: Maximum 101.3 Weeks | STARTED | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) | 5 | |
| Dose Escalation: Maximum 101.3 Weeks | STARTED | Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) | 5 | |
| Dose Escalation: Maximum 101.3 Weeks | STARTED | Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) | 4 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 participant flowAdverse events6,976
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) | 1 | 2 | |
| other | Diarrhoea | Gastrointestinal disorders | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) | 0 | 1 | |
| other | Diarrhoea | Gastrointestinal disorders | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) | 0 | 1 | |
| other | Diarrhoea | Gastrointestinal disorders | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) | 0 | 1 | |
| other | Diarrhoea | Gastrointestinal disorders | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) | 3 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) | 7 | 18 | |
| other | Diarrhoea | Gastrointestinal disorders | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) | 2 | 7 | |
| other | Diarrhoea | Gastrointestinal disorders | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) | 2 | 5 | |
| other | Diarrhoea | Gastrointestinal disorders | Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) | 2 | 5 | |
| other | Diarrhoea | Gastrointestinal disorders | Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) | 1 | 4 |
1 to 10 of 6,976Source ClinicalTrials.gov
See all 6,976 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) | 2 | 2 |
| Total, all-cause mortality | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) | 0 | 1 |
| Total, all-cause mortality | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) | 0 | 1 |
| Total, all-cause mortality | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) | 0 | 1 |
| Total, all-cause mortality | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) | 0 | 9 |
| Total, all-cause mortality | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) | 1 | 18 |
| Total, all-cause mortality | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) | 0 | 7 |
| Total, all-cause mortality | Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) | 0 | 5 |
| Total, all-cause mortality | Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) | 0 | 5 |
| Total, all-cause mortality | Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) | 0 | 4 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT01609556/registered?page=2