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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.Check my eligibility
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.See study design
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 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

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,595 Previous Clinical Trials
12,868,550 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,045,159 Total Patients Enrolled
~147 spots leftby Jan 2028