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Virus Therapy

PF-07329640 for Solid Tumors (LTbR Trial)

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

Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor

Participants with 'cold' solid tumors where anti-PD-(L)1 therapy is not an established treatment

Must not have

Brain metastasis or primary brain tumor requiring immediate local intervention

Treatment with any systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to planned first dose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years

Awards & highlights

Summary

This trial aims to study the safety and effects of a new drug, PF-07329640, for treating solid tumors such as lung cancer, colorectal cancer, urothelial cancer, and

Who is the study for?

Participants with advanced or metastatic solid tumors, including NSCLC, CRC, UC, and melanoma. They will receive PF-07329640 via IV infusion weekly for 28-day cycles and may also get bevacizumab every two weeks or sasanlimab every four weeks.

What is being tested?

The trial is testing the safety and effects of PF-07329640 alone or combined with bevacizumab or sasanlimab on various cancers. It aims to determine the optimal dosing while monitoring participants' responses over up to four years.

What are the potential side effects?

Potential side effects include reactions related to IV infusions, possible immune system impacts due to cancer medications which could lead to inflammation in different body parts, fatigue, skin reactions at injection sites, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced, cannot be surgically removed, and has either spread or not responded to treatment.

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My cancer is not typically treated with anti-PD-(L)1 therapy.

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I have colorectal cancer and have been treated with specific chemotherapies and targeted therapies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need immediate treatment for a brain tumor or cancer spread to my brain.

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I haven't had cancer treatment in the last 4 weeks or 5 half-lives, whichever is shorter.

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I am currently being treated for an infection.

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I have had an organ or bone marrow transplant and am on immunosuppressants.

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I have ongoing nerve pain or tingling that is moderate or worse.

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My kidney, liver, and bone marrow are working well.

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I have been treated with an anti-LTβR agonist before.

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I have an autoimmune disease treated with long-term steroids or immune therapies.

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I have had a severe reaction to previous immune therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years'

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years'

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 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

PART 1 & 2: Incidence of Adverse Events (AE)s

PART 1: Number of participants with Dose-limiting toxicities (DLT)

Part 2: "Objective Response - Number of Participants With Objective Response "

+1 more

Secondary outcome measures

Incidence and titers of antidrug antibodies (ADA) against PF-07329640

Paired Tumor Biopsies

Part 1: Objective Response - Number of Participants With Objective Response

+6 more

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part 2D: PF-07329640 (αLTβR)Experimental Treatment1 Intervention

PF-07329640 (αLTβR) dose expansion in advanced solid tumors at prescribed dose and frequency in 28-day cycles

Group II: Part 2C: PF-07329640 (αLTβR) + SOCExperimental Treatment1 Intervention

PF-07329640 (αLTβR) + SOC (anti-PD-1+ platinum-based chemo) dose expansion for αPDx-naïve NSCLC 1L at prescribed dose and frequency in 28-day cycles

Group III: Part 2B: PF-07329640 (αLTβR) + sasanlimabExperimental Treatment2 Interventions

PF-07329640 (αLTβR) + sasanlimab dose expansion in NSCLC, melanoma, UC, and MSS CRC at prescribed dose and frequency in 28-day cycles

Group IV: Part 2A: PF-07329640 (αLTβR) + bevacizumabExperimental Treatment2 Interventions

PF-07329640 (αLTβR) + bevacizumab dose expansion in NSCLC 2L+ and MSS CRC 2L+ at prescribed dose and frequency in 28-day cycles

Group V: Part 1C: PF-07329640 (αLTβR) + sasanlimabExperimental Treatment2 Interventions

PF-07329640 (αLTβR) + sasanlimab dose escalation in NSCLC, melanoma, UC, and MSS CRC at prescribed dose and frequency in 28-day cycles

Group VI: Part 1B: PF-07329640 (αLTβR) + bevacizumabExperimental Treatment2 Interventions

PF-07329640 (αLTβR) + bevacizumab dose escalation in NSCLC and MSS CRC at prescribed dose and frequency in 28-day cycles

Group VII: Part 1A: PF-07329640 (αLTβR) MonotherapyExperimental Treatment1 Intervention

PF-07329640 (αLTβR) monotherapy at prescribed dose and frequency in 28-day cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

bevacizumab

2002

Completed Phase 3

~3360

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,595 Previous Clinical Trials

12,868,582 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,496 Previous Clinical Trials

10,045,191 Total Patients Enrolled

~147 spots leftby Jan 2028

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