PF-08634404 Combinations for Lung Cancer

Recruiting at 30 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Pfizer

Must not be taking: Immunotherapy, Anti-angiogenic therapy

Disqualifiers: EGFR, ALK, ROS1, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

162 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new medicine, PF-08634404, to assess its effectiveness with other cancer medicines in individuals with advanced non-small cell lung cancer (NSCLC) that has spread and cannot be treated surgically. Researchers aim to determine the safety of this combination and identify potential side effects. The study consists of different parts, each testing PF-08634404 with another cancer treatment, such as sigvotatug vedotin. Participants will receive these medicines through an IV drip at a clinic. Those with advanced NSCLC that has spread and are not candidates for surgery or certain other treatments may be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown promising results when patients received PF-08634404. Whether used alone or with chemotherapy, this medicine demonstrated a manageable safety profile. Patients tolerated it well, with side effects deemed acceptable for cancer treatment.

Research also indicates that combining PF-08634404 with sigvotatug vedotin is generally safe. Sigvotatug vedotin, another medicine under exploration for cancer treatment, has shown side effects that patients can handle and are not too severe.

Both treatments remain under study, so researchers continue to learn about all possible side effects and safety details. However, findings so far suggest that these medicines, either alone or together, are tolerable for patients with advanced cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for lung cancer, like chemotherapy and immunotherapy, focus on killing cancer cells directly or boosting the immune response against them. However, PF-08634404 is unique because it targets specific cancer-related pathways, potentially disrupting cancer cell growth and survival more precisely. Researchers are excited about PF-08634404 combined with Sigvotatug Vedotin because it combines a novel agent with a targeted therapy, offering a new way to attack cancer cells. Additionally, the combination with other anticancer agents opens up possibilities for enhanced effectiveness, potentially leading to better outcomes for patients compared to existing treatments.

What evidence suggests that this trial's treatments could be effective for advanced non-small cell lung cancer?

In this trial, participants will receive PF-08634404 combined with other anticancer agents. Earlier research has shown promising results for PF-08634404 when paired with chemotherapy for non-small cell lung cancer (NSCLC). This compound targets proteins called PD-1 and VEGF, which aid tumor growth. Studies have found that combining PF-08634404 with chemotherapy can lead to strong and lasting responses in some patients.

Another arm of this trial involves PF-08634404 combined with Sigvotatug Vedotin. Early studies suggest that Sigvotatug Vedotin is safe and shows promise in treating NSCLC. This drug is a targeted cancer therapy that delivers powerful medicine directly to cancer cells. Together, these treatments aim to improve outcomes for people with advanced lung cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Inclusion Criteria

My cancer's PD-L1 status is known.

My lung cancer is advanced and cannot be treated with surgery or combined chemo and radiation.

My cancer can be measured by standard health scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive PF-08634404 in combination with Sigvotatug Vedotin through IV infusion

Up to 5 years

Regular visits at clinical trial sites

Treatment Part B

Participants receive PF-08634404 in combination with other anticancer agents through IV infusion

Up to 5 years

Regular visits at clinical trial sites

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 37 days after the last dose of treatment

What Are the Treatments Tested in This Trial?

Interventions

• PF-08634404
• Sigvotatug Vedotin

How Is the Trial Designed?

Group I: PF-08634404 + Sigvotatug Vedotin (Part A) Experimental Treatment 2 Interventions

Participants will receive PF-08634404 in combination with Sigvotatug Vedotin.

Group II: PF-08634404 + Combination Agent 1 (Part B) Experimental Treatment 2 Interventions

Participants will receive PF-08634404 in combination with other anticancer agents as per protocol.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1.

esmoopen.com

esmoopen.com/article/S2059-7029(26)00696-4/fulltext

440TiP A phase II/III trial of a PD-1/VEGF bispecific ...

Phase II studies have shown promising efficacy and manageable safety with PF-08634404 as a monotherapy and with chemotherapy in first-line non-small cell lung ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07222566

NCT07222566 | Symbiotic-Lung-01 : A Study to Learn ...

This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment ...

3.

medicine.yale.edu

medicine.yale.edu/publication-details/phase-ii-iii-trial-of-pd-1-vegf-antibody-in-small-cell-lung-cancer/

Phase II/III Trial of PD-1/VEGF Antibody in Small Cell Lung ...

This study examines the effectiveness and safety of a new treatment approach combining PF-08634404, a bispecific antibody targeting PD-1 (a ...

4.

jitc.bmj.com

jitc.bmj.com/content/13/Suppl_3/A1568

1328 SSGJ-707, a PD-1/VEGF bispecific antibody ...

Conclusions SSGJ-707 combined with platinum-based chemotherapy demonstrated manageable safety and promising efficacy in first-line treatment of ...

5.

pfizeroncologydevelopment.com

pfizeroncologydevelopment.com/clinical_trial/NCT07226999

PD-1 x VEGF Bispecific Antibody

PF-08634404 is an investigational compound. Its safety and efficacy have not been established. A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07489066

Symbiotic-Lung-10: A Study to Learn About PF-08634404 ...

The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non- ...

7.

pfizerclinicaltrials.com

pfizerclinicaltrials.com/find-a-trial/nct07222566-advanced-non-small-cell-lung-cancer-trial

Clinical Trial for Advanced Non-Small Cell Lung Cancer ...

This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment ( ...