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Monoclonal Antibodies

Monotherapy dose escalation (Part 1A) for Tumors

Phase 1

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through up to 2 years

Awards & highlights

Study Summary

This trial aims to test the safety and effectiveness of PF-07820435 alone or in combination with sasanlimab in patients with advanced or metastatic solid tumors. The first part of the study

Who is the study for?

This trial is for adults with certain advanced cancers (like lung, kidney, colorectal) who've tried standard treatments without success or can't tolerate them. They need at least one measurable tumor and must provide tissue samples. It's not open to those who haven't had specific prior therapies if available and tolerable.Check my eligibility

What is being tested?

The study tests PF-07820435 alone and with Sasanlimab in patients with advanced solid tumors. Part 1 finds the best dose; Part 2 uses this dose to see how well it works in different cancer types.See study design

What are the potential side effects?

While the side effects aren't listed here, similar cancer drugs often cause fatigue, nausea, skin reactions, immune-related issues like inflammation of organs, and increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with adverse events (AEs)

Number of patients with clinically significant lab abnormalities

Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B)

+1 more

Secondary outcome measures

AUC of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2

AUClast (area under the curve from time 0 to the last measurable timepoint) of PF-07820435 and its active metabolite

Change from baseline of immune markers within biopsied tumor tissue

+10 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Monotherapy dose escalation (Part 1A)Experimental Treatment1 Intervention

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

Group II: Expansion (Part 2) - Tumor specific Arm BExperimental Treatment2 Interventions

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

Group III: Expansion (Part 2) - Tumor specific Arm AExperimental Treatment2 Interventions

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

Group IV: Expansion (Part 2) - Arm CExperimental Treatment1 Intervention

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

Group V: Combination dose escalation (Part 1B)Experimental Treatment2 Interventions

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,592 Total Patients Enrolled

4 Trials studying Tumors

1,873 Patients Enrolled for Tumors

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,091,810 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants being recruited for this clinical investigation?

"The successful execution of this study mandates the recruitment of 140 eligible participants. The renowned pharmaceutical company Pfizer will oversee operations at various locations, such as Corewell Health in Grand Rapids, Michigan (as referenced in a non-engagement letter) and START Midwest in Kashiwa, Chiba."

Answered by AI

In how many distinct settings is this medical study being conducted?

"This clinical trial offers enrollment at 6 sites, such as Corewell Health in Grand Rapids with a non-engagement letter reference, START Midwest in Kashiwa, and National Cancer Center Hospital East in Rio Piedras. Additionally, there are opportunities available at 6 more locations."

Answered by AI

Is the process of enrolling participants currently underway for this clinical trial?

"Indeed, the details on clinicaltrials.gov indicate that this study is actively seeking candidates. The trial was initially published on February 8th, 2024 and last revised on April 2nd, 2024. Recruitment aims to include 140 participants distributed among six designated sites."

Answered by AI

What are the anticipated results that researchers hope to achieve through conducting this study?

"The primary focus of this clinical trial, to be evaluated over a period spanning from baseline up to 2 years, is the identification of patients exhibiting noteworthy abnormalities in laboratory test results. Secondary objectives involve examining the minimum concentration (Cmin) of PF-07820435 and its metabolite following multiple doses, along with parameters related to pharmacokinetics after single and multiple administrations such as time taken to reach peak plasma concentrations (Tmax), as well as assessing area under the curve until the last measurable point in relation to both compounds."

Answered by AI

What are the safety considerations surrounding Monotherapy dose escalation for individuals participating in Part 1A of this study?

"Our team at Power assesses the safety of Monotherapy dose escalation (Part 1A) to be a level 1 on our scale, attributed to this being a Phase 1 trial with minimal data supporting both efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06285097.

All > Cancer > Immunotherapy