Trial · NCT02663518
A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors
NCT02663518, Phase 1, Terminated, Pfizer; results first posted 2024-05-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors. Trials, record NCT02663518. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02663518
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors
- NCT number
- NCT02663518
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 249 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Hematologic Malignancies, Solid Tumor
- Interventions
- PF-0791800 (TTI-621), PF-07901800 (TTI-621) plus Rituximab, PF-07901800 (TTI-621) plus Nivolumab
- First posted
- 2016-01-26
- Last updated
- 2024-05-10
- Results first posted
- 2024-05-10
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Part 1: Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 1 was 414 days) | An adverse event (AE) was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state. |
| Primary | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Part 1: Day 1 of dosing up to Pre-dose on Day 22 | DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration ( Absolute Neutrophil Count (ANC) less than (\<) 1.0 \* 10\^9/L. fever greater than (\>) 38.5° Degree Celsius (C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage. |
| Primary | Part 2 and 3: Number of Participants With TEAEs and TESAEs | Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days) | An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state. |
| Primary | Part 4: Number of Participants With TEAEs and TESAEs | Part 4: Day 1 of dosing up to 1 year of safety follow-up visit after the last dose (maximum treatment exposure for Part 4 was 667 days) | An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state. |
| Primary | Part 4: Number of Participants With Dose Limiting Toxicities (DLTs) | Part 4: Day 1 of dosing up to Pre-dose on Day 22 | DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration (ANC \< 1.0 x 109/L, fever \> 38.5°C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage. |
| Secondary | Part 1: Maximum Plasma Concentration (Cmax) of TTI-621 | Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1 | |
| Secondary | Part 1: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621 | Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1 | |
| Secondary | Part 1: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells | Part 1: Week 1 end of infusion (EOI) | CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumour cells . |
| Secondary | Part 1: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb) | Part 1: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 1 was 414 days) | A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participants had \>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \> \[4-fold dilution increase\] in titer from baseline in \>1 post-treatment sample (treatment-boosted). |
| Secondary | Part 2 and 3 Combined: Maximum Plasma Concentration (Cmax) of TTI-621 | Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1 | Results for this outcome measure was reported for Part 2 and Part 3 combined. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Part 1: Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 1 was 414 days) | Safety population included all the participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Part 1: Day 1 of dosing up to Pre-dose on Day 22 | The DLT-evaluable set included participants who had received all 3 doses within the DLT evaluation period, or participants who experienced an AE, meeting DLT criteria during that time. Here, Number of Participants Analyzed refers to participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2 and 3: Number of Participants With TEAEs and TESAEs | Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days) | Analysis population included all the participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 4: Number of Participants With TEAEs and TESAEs | Part 4: Day 1 of dosing up to 1 year of safety follow-up visit after the last dose (maximum treatment exposure for Part 4 was 667 days) | Analysis population included all the participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 4: Number of Participants With Dose Limiting Toxicities (DLTs) | Part 4: Day 1 of dosing up to Pre-dose on Day 22 | The DLT-evaluable set included participants who had received all 3 doses within the DLT evaluation period, OR participants who experienced an AE, meeting DLT criteria during that time. As 2.0mg/kg Q2W cohort was not a part of escalation for dose optimization, and not relevant to DLT assessment hence this outcome measure was not analyzed for Q2W arm. Here, Number of Participants Analyzed refers to participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1: Maximum Plasma Concentration (Cmax) of TTI-621 | Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1 | Pharmacokinetic (PK)-evaluable set included treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter. | Nanogram per milliliter | MEAN |
| SECONDARY | Part 1: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621 | Part 1: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1 | PK evaluable set included treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter. Here, Number of Participants Analyzed refers to participants evaluable for this outcome measure. | Nanogram*hour/milliliter | MEAN |
| SECONDARY | Part 1: Percentage of CD47 Receptor Occupancy on Peripheral Blood CD3+ Cells | Part 1: Week 1 end of infusion (EOI) | This outcome measure was not analyzed since CD47 data for Part 1 was not collected as the assay was not set up when enrolling the Part 1 participants. Hence, no participants evaluable for this outcome measure. | ||
| SECONDARY | Part 1: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb) | Part 1: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 1 was 414 days) | Immunogenicity analysis population included all treated participants with at least one ADA sample (pre-dose or post-treatment) analyzed. Here, Number of Participants Analyzed signifies number of participants who were ADA or NAb evaluable. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2 and 3 Combined: Maximum Plasma Concentration (Cmax) of TTI-621 | Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1 | PK evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, Number of participants analyzed signifies number of evaluable participants for this outcome measure. | Nanogram per milliliter | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group143
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg | TEAEs | 3 | Participants | |
| Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg | TEAEs | 3 | Participants | |
| Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg | TEAEs | 7 | Participants | |
| Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg | TEAEs | 5 | Participants | |
| Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg | TESAEs | 1 | Participants | |
| Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg | TESAEs | 0 | Participants | |
| Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg | TESAEs | 1 | Participants | |
| Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg | TESAEs | 2 | Participants | |
| Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg | 0 | Participants | ||
| Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg | 0 | Participants |
1 to 10 of 143Source ClinicalTrials.gov
See all 143 results by groupParticipant flow126
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1: Phase 1a Escalation | STARTED | Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg | 3 | |
| Part 1: Phase 1a Escalation | STARTED | Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg | 3 | |
| Part 1: Phase 1a Escalation | STARTED | Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg | 7 | |
| Part 1: Phase 1a Escalation | STARTED | Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg | 5 | |
| Part 1: Phase 1a Escalation | STARTED | Ontorpacept (PF-07901800/TTI-621) Monotherapy for Part 2 | 0 | |
| Part 1: Phase 1a Escalation | STARTED | Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination | 0 | |
| Part 1: Phase 1a Escalation | STARTED | Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination | 0 | |
| Part 1: Phase 1a Escalation | STARTED | Ontorpacept (PF-07901800/TTI-621) Monotherapy for Part 3 | 0 | |
| Part 1: Phase 1a Escalation | STARTED | Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg | 0 | |
| Part 1: Phase 1a Escalation | STARTED | Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg | 0 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 participant flowAdverse events1,610
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 | Fatigue | General disorders | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg | 1 | 3 | |
| other | Fatigue | General disorders | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg | 2 | 3 | |
| other | Fatigue | General disorders | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg | 4 | 7 | |
| other | Fatigue | General disorders | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg | 2 | 5 | |
| other | Fatigue | General disorders | Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 39 | 107 | |
| other | Fatigue | General disorders | Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination | 0 | 11 | |
| other | Fatigue | General disorders | Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination | 18 | 40 | |
| other | Fatigue | General disorders | Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 13 | 42 | |
| other | Fatigue | General disorders | Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg | 1 | 3 | |
| other | Fatigue | General disorders | Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg | 0 | 3 |
1 to 10 of 1,610Source ClinicalTrials.gov
See all 1,610 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg | 0 | 3 |
| Total, all-cause mortality | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg | 1 | 3 |
| Total, all-cause mortality | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg | 1 | 7 |
| Total, all-cause mortality | Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg | 1 | 5 |
| Total, all-cause mortality | Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 52 | 107 |
| Total, all-cause mortality | Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination | 0 | 11 |
| Total, all-cause mortality | Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination | 27 | 40 |
| Total, all-cause mortality | Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 16 | 42 |
| Total, all-cause mortality | Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg | 0 | 3 |
| Total, all-cause mortality | Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg | 0 | 3 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part 2: Myelodysplastic Syndrome (MDS) vs Part 2: Myeloproliferative Neoplasms (MPN): Part 2: Overall Response Rate (ORR)-Savona 2015- Disease Indication | Trial comparisons |
| Parts 2 and 3 : Cutaneous T-cell Lymphoma (CTCL) vs Parts 2 and 3: T-cell Lymphoma (TCL): Parts 2 and 3: Overall Response Rate (ORR)-Olsen 2011-Disease Indication | 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/NCT02663518
GET https://conductscience.org/api/trials/v1/NCT02663518/registered?page=2