Clinical trial · Interventional
Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies
A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE PHARMACOKINETICS, SAFETY, EFFICACY, AND PHARMACODYNAMICS OF PF-06801591 (PD-1 INHIBITOR) IN PARTICIPANTS WITH ADVANCED MALIGNANCIES
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1b/2 protocol to evaluate pharmacokinetics, safety, efficacy, and pharmacodynamics of PF-06801591, a programmed death-1(PD-1) antagonist monoclonal antibody (mAb) in participants with advanced malignancies. This study consists of 2 parts: Phase 1b part (dose escalation and dose expansion) in patients with advanced malignancies in Asia and a global Phase 2 part in non small cell lung cancer (NSCLC) patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancies | — | UNRESOLVED | — |
| Non-small-cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-06801591 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A1 (Phase 1b)
- interventionNames
- Drug: PF-06801591
- type
- EXPERIMENTAL
- label
- Arm B1 (Phase 1b)
- interventionNames
- Drug: PF-06801591
- type
- EXPERIMENTAL
- label
- Arm A2 (Phase 2)
- interventionNames
- Drug: PF-06801591
- type
- EXPERIMENTAL
- label
- Arm B2 (Phase 2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years (≥ 20 years in Japan; ≥ 19 years in South Korea) * Easter Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate bone marrow function, renal and liver functions Phase 1b * Histological or Cytological diagnosis of advanced solid tumor with clinical evidence of response to anti-PD-1 or PD-L1 agent * Participant must have received at least 1 prior line of therapy for recurrent or metastatic disease, and must have progressed/relapsed, be refractory, or intolerant to standard therapy approved for the specific tumor type Phase 2 * Participants must have a documented diagnosis of stage III where participants are not candidates for surgical resection or definitive chemoradiation, or stage IV NSCLC * EGFR mutation, BRAF mutation, and ALK or ROS1 translocation/rearrangement are not permitted * Participants whose tumor is known to be PD-L1 positive (Tumor Proportion Score \[TPS\] ≥1%) or unknown are eligible * Up to 1 line of prior therapy in advanced or metastatic disease settings allowed * Participant should not have received prior treatment with anti PD-1/PD-L1 drugs * At least one measurable lesion as defined by RECIST version 1.1 Exclusion Criteria: * Participants with known symptomatic brain metastases requiring steroids * Participants with Interstitial Lung Disease history or complication * Q-T interval corrected for heart rate QTc \> 450 msec for male participants or QTc \> 470 msec for female participants or QTc \> 480 msec in participants with right bundle branch block. * Hypertension that cannot be controlled by medications (eg, systolic \> 150 mmHg and diastolic \> 90 mmHg) despite optimal medical therapy. * Known or suspected hypersensitivity to active ingredient or excipients of the study drug. * History of Grade ≥3 immune mediated AE (including AST/ ALT elevations that where considered drug related and cytokine release syndrome \[CRS\]) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy (For Phase 1b only). * Vaccination with live attenuated vaccines within 4 weeks prior to randomization is prohibited; however inactivated vaccines are permitted.
References
Publications (1)
- DERIVEDPenkov K, Bondarenko I, Saenko DV, Kulyaba Y, Guo J, Gong Y, Yamamoto N, Hotko YS, Boyko V, Fadeeva NV, Ursol GM, Ahn HK, Kislov NV, Shen CI, Davis C, Kowalski K, Michelon E, Pavlov D, Hirohashi T, Cho BC. Pharmacokinetics, safety, and efficacy of an alternative dosing regimen of sasanlimab in participants with advanced NSCLC and other malignancies. Ther Adv Med Oncol. 2024 Sep 11;16:17588359241274592. doi: 10.1177/17588359241274592. eCollection 2024. PMID 39281971