Trial · NCT05483933
Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers
NCT05483933, Phase 1, Completed, Shattuck Labs, Inc.; results first posted 2025-12-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers. Trials, record NCT05483933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05483933
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers
- NCT number
- NCT05483933
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 86 participants, actual
- Lead sponsor
- Shattuck Labs, Inc.
- Conditions
Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer, Epithelial Ovarian Cancer, Ovarian Cancer, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Primary Peritoneal Carcinoma
- Interventions
- Pegylated Liposomal Doxorubicin + SL-172154, Mirvetuximab + SL-172154
- First posted
- 2022-08-02
- Last updated
- 2025-12-23
- Results first posted
- 2025-12-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate Safety and Tolerability of SL-172154 When Administered With PLD or Mirvetixumab | From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months | Number of participants with treatment emergent adverse events from dose escalation and expansion cohorts |
| Primary | Establish the Recommended Phase 2 Dose (RP2D) for SL-172154 When Administered With PLD or Mirvetixumab | From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months | Based on review of all data, including safety, tolerability, PK, antitumor activity, and PD effects" |
| Secondary | To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab | approximately 24 months | Overall response rate per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) |
| Secondary | Immunogenicity to SL-172154 | approximately 24 months | Number and proportion of participants with positive anti-drug antibody titer of those who were ADA negative at baseline |
| Secondary | Immunogenicity to MIRV | approximately 24 months | Number and proportion of participants with positive anti-drug antibody titer of those who were ADA negative at baseline |
| Secondary | Maximum Serum Concentration (Cmax) of SL-172154 | C1D8, C1D15, C2D8 | The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses |
| Secondary | Area Under the Serum Concentration-time Curve (AUC) of SL-172154 | C1D8, C1D15 and C2D8 | The AUC is the area under the serum concentration time curve of SL-172154 following single and multiple doses |
| Secondary | Time at Which Maximum Concentration of SL-172154 is Observed (Tmax) | C1D8, C1D15 and C2D8 | The Tmax is the time at which the maximum concentration of SL-172154 is observed following single and multiple doses |
| Secondary | Maximum Serum Concentration (Cmax) of MIRV | Day 1 of each cycle, pre-dose and end of infusion (EOI) | The Cmax is the maximum observed serum concentration of MIRV following single and multiple doses |
| Secondary | Maximum Serum Concentration (Cmax) of Total Antibody (MIRV) | Day 1 of each cycle, pre-dose and end of infusion (EOI) | The Cmax is the maximum observed serum concentration of Total Antibody (MIRV) following single and multiple doses |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluate Safety and Tolerability of SL-172154 When Administered With PLD or Mirvetixumab | From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months | Subjects who received at least one dose of SL-172154, PLD or Mirvetixumab | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab | approximately 24 months | Response Evaluable Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Immunogenicity to SL-172154 | approximately 24 months | Immunogenicity population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Immunogenicity to MIRV | approximately 24 months | Immunogenicity population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Serum Concentration (Cmax) of SL-172154 | C1D8, C1D15, C2D8 | PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Serum Concentration-time Curve (AUC) of SL-172154 | C1D8, C1D15 and C2D8 | PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time at Which Maximum Concentration of SL-172154 is Observed (Tmax) | C1D8, C1D15 and C2D8 | PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis. | hours | MEDIAN |
| SECONDARY | Maximum Serum Concentration (Cmax) of MIRV | Day 1 of each cycle, pre-dose and end of infusion (EOI) | PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Establish the Recommended Phase 2 Dose (RP2D) for SL-172154 When Administered With PLD or Mirvetixumab | From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months | DLT evaluable population (Dose Escalation only) | mg/kg | NUMBER |
| SECONDARY | Maximum Serum Concentration (Cmax) of Total Antibody (MIRV) | Day 1 of each cycle, pre-dose and end of infusion (EOI) | PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis. | ng/mL | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Evaluate Safety and Tolerability of SL-172154 When Administered With PLD or Mirvetixumab | Pegylated Liposomal Doxorubicin + SL-172154 | 20 | Participants | ||
| Evaluate Safety and Tolerability of SL-172154 When Administered With PLD or Mirvetixumab | Mirvetixumab + SL-172154 | 65 | Participants | ||
| To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab | Pegylated Liposomal Doxorubicin + SL-172154 | Complete response | 0 | Participants | |
| To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab | Mirvetixumab High (PS2+ ≥75%) + SL-172154 | Complete response | 1 | Participants | |
| To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab | Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154 | Complete response | 0 | Participants | |
| To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab | Pegylated Liposomal Doxorubicin + SL-172154 | Partial response | 4 | Participants | |
| To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab | Mirvetixumab High (PS2+ ≥75%) + SL-172154 | Partial response | 12 | Participants | |
| To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab | Mirvetixumab Low+Medium ((PS2+ ≥25% to <75%) + SL-172154 | Partial response | 4 | Participants | |
| To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab | Pegylated Liposomal Doxorubicin + SL-172154 | Stable Disease | 10 | Participants | |
| To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab | Mirvetixumab High (PS2+ ≥75%) + SL-172154 | Stable Disease | 21 | Participants |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pegylated Liposomal Doxorubicin + SL-172154 | 21 | |
| Overall Study | STARTED | Mirvetuximab + SL-172154 | 65 | |
| Overall Study | COMPLETED | Pegylated Liposomal Doxorubicin + SL-172154 | 21 | |
| Overall Study | COMPLETED | Mirvetuximab + SL-172154 | 65 | |
| Overall Study | NOT COMPLETED | Pegylated Liposomal Doxorubicin + SL-172154 | 0 | |
| Overall Study | NOT COMPLETED | Mirvetuximab + SL-172154 | 0 |
Source ClinicalTrials.gov
Adverse events192
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 | Nausea | Gastrointestinal disorders | Pegylated Liposomal Doxorubicin + SL-172154 | 11 | 21 | |
| other | Nausea | Gastrointestinal disorders | Mirvetuximab + SL-172154 | 32 | 65 | |
| other | Constipation | Gastrointestinal disorders | Pegylated Liposomal Doxorubicin + SL-172154 | 9 | 21 | |
| other | Constipation | Gastrointestinal disorders | Mirvetuximab + SL-172154 | 18 | 65 | |
| other | Abdominal pain | Gastrointestinal disorders | Pegylated Liposomal Doxorubicin + SL-172154 | 6 | 21 | |
| other | Abdominal pain | Gastrointestinal disorders | Mirvetuximab + SL-172154 | 17 | 65 | |
| other | Diarrhoea | Gastrointestinal disorders | Pegylated Liposomal Doxorubicin + SL-172154 | 4 | 21 | |
| other | Diarrhoea | Gastrointestinal disorders | Mirvetuximab + SL-172154 | 30 | 65 | |
| other | Stomatitis | Gastrointestinal disorders | Pegylated Liposomal Doxorubicin + SL-172154 | 6 | 21 | |
| other | Stomatitis | Gastrointestinal disorders | Mirvetuximab + SL-172154 | 4 | 65 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pegylated Liposomal Doxorubicin + SL-172154 | 12 | 21 |
| Total, all-cause mortality | Mirvetuximab + SL-172154 | 30 | 65 |
| Total, other adverse events | Pegylated Liposomal Doxorubicin + SL-172154 | 20 | 21 |
| Total, other adverse events | Mirvetuximab + SL-172154 | 65 | 65 |
| Total, serious adverse events | Pegylated Liposomal Doxorubicin + SL-172154 | 4 | 21 |
| Total, serious adverse events | Mirvetuximab + SL-172154 | 17 | 65 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41951722 | DERIVED |
Source PubMed
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pegylated Liposomal Doxorubicin + SL-172154 vs Mirvetixumab + SL-172154: Evaluate Safety and Tolerability of SL-172154 When Administered With PLD or Mirvetixumab | Trial comparisons |
| Pegylated Liposomal Doxorubicin + SL-172154 vs Mirvetuximab + SL-172154: deaths from any cause | Trial comparisons |
| Pegylated Liposomal Doxorubicin + SL-172154 vs Mirvetuximab + SL-172154: Immunogenicity to SL-172154 | Trial comparisons |
| Pegylated Liposomal Doxorubicin + SL-172154 vs Mirvetuximab + SL-172154: serious adverse events | Trial comparisons |
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05483933
GET https://conductscience.org/api/trials/v1/NCT05483933/results?page=2