What side effects are associated with this type of intervention?

Common treatments for gastric cancer, including chemotherapy agents like paclitaxel, cisplatin, and fluorouracil, often result in side effects such as nausea, vomiting, diarrhea, fatigue, and myelosuppression (decreased production of blood cells). Targeted therapies like ramucirumab and bevacizumab, which inhibit angiogenesis, can cause hypertension, proteinuria, and an increased risk of bleeding and thromboembolic events. These treatments may also lead to gastrointestinal perforations and fistula formation in some cases.

What prior FDA approvals exist?

Several FDA-approved treatments for gastric cancer target cancer cells in gastric adenocarcinoma and gastroesophageal junction adenocarcinoma. Pembrolizumab, an anti-PD-1 monoclonal antibody, has shown efficacy in advanced refractory PD-L1-expressing esophagogastric adenocarcinoma. Ramucirumab, a VEGFR-2 inhibitor, has demonstrated survival benefits in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, both as a monotherapy and in combination with paclitaxel. These treatments focus on inhibiting specific pathways involved in tumor growth and survival, similar to the investigational approach of PT886.

What other types of research exist?

Promising novel alternatives to PT886 for gastric cancer patients include: <ol> <li>Immune checkpoint inhibitors such as anti-PD-1 or anti-PD-L1 therapies, which have shown efficacy in various cancers including gastric cancer.</li> <li>mTOR inhibitors like temsirolimus, which have been evaluated in clinical trials for their potential in treating recurrent or metastatic cancers.</li> <li></li> </ol> Antisense oligonucleotides targeting Ku86, which may enhance the efficacy of radiotherapy and DNA-damaging agents in tumor treatment. 4. Novel imidazotetrazine analogues like DP68, which have demonstrated potent antiglioblastoma activity and may offer benefits in overcoming drug resistance.

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Monoclonal Antibodies

PT886 for Stomach Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Phanes Therapeutics

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 through study completion, an average of 2 years

Awards & highlights

Summary

This trial tests a new drug, PT886, on patients with advanced stomach, gastroesophageal, and pancreatic cancers. Researchers aim to see if it is safe and effective by observing its effects on the body and tumors.

Who is the study for?

This trial is for adults with advanced or metastatic stomach, gastroesophageal junction, or pancreatic cancers that have no standard treatment options left. Participants must be over 18, able to consent, and meet health criteria like a specific performance status and adequate organ function. They should not be pregnant and agree to use effective contraception.

What is being tested?

PT886 is being tested in this study; it's a new antibody targeting proteins often found on certain cancer cells which may help the immune system destroy these cells. The trial will check how safe PT886 is, what the body does with it (pharmacokinetics), and if it helps against cancer.

What are the potential side effects?

Potential side effects of PT886 are not detailed here but could include typical reactions related to immune therapies such as infusion-related symptoms, fatigue, allergic reactions, or issues affecting different organs due to an enhanced immune response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the dose-limiting toxicity (DLT) of PT886.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention

Two dose levels will be explored with at least 10 patients in each; the recommended dose for expansion (RDE) from Part A, and another dose level. The RDE may be the MTD or a lower dose level. Additional dose levels and regiments such as, Q2W and/or Q3W dose evaluations may be performed.

Group II: Dose EscalationExperimental Treatment1 Intervention

An accelerated titration design will be employed, and 1 patient will be enrolled initially at each of the lower dose levels: 0.1 mg/kg, 0.3 mg/kg and 1 mg/kg. At Dose Level 4 (3 mg/kg), the standard 3+3 design will be implemented.

Group III: Combination Expansion with KEYTRUDA® (pembrolizumab)Experimental Treatment6 Interventions

Part D, Cohort 3: Patients with m/a GC/GEJ-C who have progressed under 1L or 2L SOC chemotherapy +/- ICI and are treatment naïve to CLDN18.2 targeting agents. Patients will receive PT886 in combination with KEYTRUDA® (pembrolizumab). Part D, Cohort 4: 1L treatment of patients with HER2 negative m/a GC/GEJ-C, that are treatment naïve to CLDN18.2 targeting agents. Patients will receive PT886 in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab). Part D, Cohort 5: Patients with m/a GC/GEJ-C, that have progressed under 1L SOC chemotherapy, and zolbetuximab, and are treatment naïve to KEYTRUDA® (pembrolizumab) or other ICI therapy for their m/a disease. Patients will receive PT886 in combination with KEYTRUDA® (pembrolizumab). Patients enrolled in Part C and D of the study must present with ≥ 10% CLDN18.2 positive TC in their tumors.

Group IV: Combination Expansion with ChemotherapyExperimental Treatment4 Interventions

Part C, Cohort 1: Patients with m/a GC/GEJ-C, that have progressed under first line (1L) SOC chemotherapy +/- ICI, and are treatment naïve to CLDN18.2 targeting agents and are eligible for second line (2L) treatment. Patients will receive PT886 in combination with Paclitaxel. Part C, Cohort 2: Patients with m/a PDAC that are treatment naïve for their 1L treatment. Patients will receive PT886 in combination with Gemcitabine plus nab-Paclitaxel (Abraxane). Patients enrolled in Part C and D of the study must present with ≥ 10% CLDN18.2 positive TC in their tumors.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abraxane

2008

Completed Phase 2

~610

Fluorouracil

2014

Completed Phase 3

~11700

Paclitaxel

2011

Completed Phase 4

~5810

Oxaliplatin

2011

Completed Phase 4

~2890

Leucovorin

2005

Completed Phase 4

~6010

Capecitabine

2013

Completed Phase 3

~3970

Gemcitabine

2017

Completed Phase 3

~1920

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for gastric cancer include targeted therapies, chemotherapy, and immunotherapy. Targeted therapies, such as those involving HER2 inhibitors like trastuzumab, work by specifically targeting and inhibiting the growth of cancer cells that overexpress the HER2 protein. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while immunotherapy, including PD-1 inhibitors, enhances the body's immune response to recognize and destroy cancer cells. Understanding these mechanisms is crucial for gastric cancer patients as it allows for personalized treatment plans that can improve efficacy and reduce side effects, ultimately leading to better outcomes.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,950 Previous Clinical Trials

5,174,869 Total Patients Enrolled

Phanes TherapeuticsLead Sponsor

2 Previous Clinical Trials

101 Total Patients Enrolled

Harold Wright, PhDStudy ChairPhanes Therapeutics SrVP of clinical development and operations

Media Library

PT886 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05482893 — Phase 1 & 2

Gastric Cancer Research Study Groups: Combination Expansion with KEYTRUDA® (pembrolizumab), Dose Expansion, Dose Escalation, Combination Expansion with Chemotherapy

Gastric Cancer Clinical Trial 2023: PT886 Highlights & Side Effects. Trial Name: NCT05482893 — Phase 1 & 2

PT886 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05482893 — Phase 1 & 2

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