A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Colorectal Carcinoma; Squamous Cell Carcinoma of the Head and Neck; Melanoma; Neoplasms; Urothelial Carcinoma; Ovarian Carcinoma; Renal Cell Carcinoma; Non-small-cell Lung Cancer

Treatments: Drug: PF-07820435; Biological: Sasanlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06285097

C5391001

NCT06285097 (Registry Identifier)

Details and patient eligibility

About

This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor
• Part 1A: Participants with solid tumors where anti-PD-(L)1 is an established treatment. Participants must have progressed on or following prior anti-PD-(L)1 therapy if approved, available, tolerable, and eligible
• Part 1B: Participants either meeting Part 1A criterion, or participants with "cold" solid tumors where anti-PD-(L)1 therapy is not an established treatment
• Part 2: Participants with NSCLC (Arm A) must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. NSCLC participants with known activating mutation(s) must also have received prior approved and available targeted therapy(ies) for the associated mutation(s) or have intolerability or documented refusal of these therapies. Participants with UC (Arm B) must have received prior platinum-based chemotherapy, anti-PD-(L)1 therapy, or enfortumab vedotin, or have documented intolerability or refusal of the standard therapy(ies). Additional cohort indication(s) or dose regimens may be added and defined based on emerging data
• At least 1 measurable lesion based on RECIST 1.1 that has not been previously irradiated (Part 1 exceptions permitted after review and approval)
• Able to provide pre-treatment (and optional on-treatment) tumor tissue

Exclusion criteria

• Active or history of clinically significant gastrointestinal disease and other conditions that are unresolved or pose a risk to study treatment or procedures
• Active or history of pneumonitis/interstitial lung disease, pulmonary fibrosis requiring treatment with systemic steroid therapy
• Active or history of clinically significant autoimmune disease or other medical condition that required chronic systemic immunosuppressive therapy within recent 2 years
• History of severe immune-mediated adverse event or cytokine release syndrome that was considered related to prior immune modulatory therapy that required immunosuppressive therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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9 participants in 5 patient groups

Monotherapy dose escalation (Part 1A)

Experimental group

Description:

Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles

Treatment:

Drug: PF-07820435

Combination dose escalation (Part 1B)

Experimental group

Description:

Participants will receive PF-07820435 orally at the prescribed dose and frequency, in combination with sasanlimab (subcutaneous injection) at a fixed dose once every 4 weeks in 28-day cycles

Treatment:

Biological: Sasanlimab

Drug: PF-07820435

Expansion (Part 2) - Tumor specific Arm A

Experimental group

Description:

Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles

Treatment:

Biological: Sasanlimab

Drug: PF-07820435

Expansion (Part 2) - Tumor specific Arm B

Experimental group

Description:

Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles

Treatment:

Biological: Sasanlimab

Drug: PF-07820435

Expansion (Part 2) - Arm C

Experimental group

Description:

Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles

Treatment:

Drug: PF-07820435