PF-07820435 + Sasanlimab for Cancer

No longer recruiting at 13 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Systemic steroids, Immunosuppressants

Disqualifiers: Gastrointestinal disease, Pneumonitis, Autoimmune, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and early effectiveness of a new cancer treatment, PF-07820435, used alone or with sasanlimab (an immunotherapy), for individuals with certain advanced or metastatic solid tumors. The trial consists of two parts: initially, it tests different doses of PF-07820435 alone or with sasanlimab, then it focuses on the optimal dose for specific tumor types. It suits those diagnosed with advanced cancer that has not responded to standard treatments like chemotherapy or for whom these treatments are not an option. Participants must have at least one measurable tumor that has not been treated with radiation. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that PF-07820435 was tested for safety in people with advanced solid tumors. However, Pfizer stopped an early trial of this treatment, possibly due to issues, though specific details about side effects remain unavailable.

More information exists for the combination treatment with sasanlimab. Other trials have studied sasanlimab, demonstrating its potential in cancer treatment. While some efficacy data is available, detailed safety results are not, indicating ongoing research into its safety.

As this is an early-stage trial, researchers primarily assess the safety of these treatments. They closely monitor participants for any side effects. Early-stage trials typically focus on safety, ensuring careful monitoring to manage potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07820435 and sasanlimab for cancer treatment because they offer a novel approach compared to current options. Unlike many existing treatments that primarily focus on chemotherapy or radiation, PF-07820435 is designed to be taken orally, making it potentially more convenient for patients. Additionally, when combined with sasanlimab, which is administered via subcutaneous injection, it may enhance the immune system's ability to target and destroy cancer cells. This combination could provide a more targeted treatment strategy, with the potential for improved outcomes and reduced side effects.

What evidence suggests that this trial's treatments could be effective for cancer?

Research shows that PF-07820435 is a new drug targeting the STING pathway, which activates the body's immune system to fight cancer. Although its effectiveness as a standalone treatment is still under investigation, early results are promising for treating solid tumors. In this trial, some participants will receive PF-07820435 alone, while others will receive it with sasanlimab. When combined with other treatments, sasanlimab has significantly reduced cancer-related issues, such as lowering the risk of disease progression in bladder cancer by 32%. Combining PF-07820435 with sasanlimab in this trial might enhance the immune system's ability to detect and destroy cancer cells. ^{1 2 3 5 6}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can provide samples of my tumor before (and possibly during) treatment.

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

I have at least one tumor that can be measured and hasn't been treated with radiation.

Exclusion Criteria

I have not been on long-term immune-weakening medicines in the last 2 years.

I have or had lung inflammation or scarring treated with steroids.

I do not have ongoing serious stomach or intestinal problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive PF-07820435 as monotherapy or in combination with sasanlimab in 28-day cycles to determine the recommended dose

28 days per cycle

Visits on Day 1, Day 8, and Day 15 of each cycle

Expansion

Participants receive PF-07820435 at the recommended dose in combination with sasanlimab for further evaluation

28 days per cycle

Visits on Day 1 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• PF-07820435
• Sasanlimab

Trial Overview 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.

How Is the Trial Designed?

Group I: Monotherapy dose escalation (Part 1A) Experimental Treatment 1 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 B Experimental Treatment 2 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 A Experimental Treatment 2 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 C Experimental Treatment 1 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 Treatment 2 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

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06285097?cond=Endocrinology&locStr=United+States&country=United+States&aggFilters=status:%2Cages:adult

NCT06285097 | A Study of PF-07820435 as a Single ... 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 ...

2. synapse.patsnap.com synapse.patsnap.com/drug/a965f9e27f934827a5c510318a2a3038

PF-07820435 - Drug Targets, Indications, Patents Clinical Results associated with PF-07820435. Login to view more data ... Phase III data released in July 2024 showed that 84% of ...

3. pharmalive.com pharmalive.com/pfizers-pipeline-pruning-ends-early-stage-sting-trial/

Pfizer's pipeline pruning ends early-stage STING trial The Phase I trial was testing PF-07820435, with or without the PD-1 inhibitor sasanlimab, in nine patients with confirmed diagnoses of solid ...

4. oncologypipeline.com oncologypipeline.com/apexonco/pfizer-hopes-not-get-stung

Pfizer hopes not to get stung | ApexOnco Trying to hit the Sting pathway hasn't gone well in the past, but Pfizer clearly hopes to do better with PF-07820435, a Sting agonist that has recently entered ...

5. biospace.com biospace.com/business/pfizers-pipeline-pruning-ends-early-stage-sting-trial

Pfizer's Pipeline Pruning Ends Early-Stage STING Trial Pfizer was studying PF-07820435, an orally available agonist of the STING protein, for solid tumors.

6. clinconnect.io clinconnect.io/trials/NCT06285097

A Study of PF-07820435 as a Single Agent and in - ClinConnect 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 ...