Your session is about to expire
← Back to Search
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
Study Summary
This trial tests a new therapy that targets 2 pathways to kill tumor cells while avoiding healthy cells, potentially offering better safety than existing treatments.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine recommended Phase 2 dose (RP2D) of PT886.
To determine the dose-limiting toxicity (DLT) of PT886.
To determine the maximum tolerated dose (MTD) of PT886.
+1 moreSecondary outcome measures
Preliminary Efficacy (assessed by the response rate by iRECIST and RECIST 1.1).
To evaluate the immunogenicity (ADA) of PT886
To evaluate the pharmacokinetics of PT886
Other outcome measures
Pharmacodynamic markers of PT886 biological activity
Pretreatment CLDN18.2 expression in correlation with primary endpoints
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
Leucovorin
2005
Completed Phase 4
~5730
Oxaliplatin
2011
Completed Phase 4
~2560
Paclitaxel
2011
Completed Phase 4
~5380
Abraxane
2008
Completed Phase 2
~610
Fluorouracil
2014
Completed Phase 3
~11540
Capecitabine
2013
Completed Phase 3
~3420
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,557 Total Patients Enrolled
Phanes TherapeuticsLead Sponsor
2 Previous Clinical Trials
92 Total Patients Enrolled
Harold Wright, PhDStudy ChairPhanes Therapeutics SrVP of clinical development and operations
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received an organ or tissue transplant from another person.My advanced stomach, GEJ, or pancreatic cancer cannot be surgically removed.I don't have another cancer that's getting worse or was treated in the last 2 years.My tumor has at least 10% CLDN18.2 positive cells.I haven't taken steroids or other immune-weakening drugs recently.I am a woman who can have children and do not use birth control.I am fully active or can carry out light work.I have untreated or worsening brain or CNS metastases.I am over 18 and can follow the study's requirements.I do not have serious heart problems.I am currently on certain blood thinner medications.I have a history of specific medical conditions or treatments.I do not have active stomach issues like perforation or blockages.I am not allergic to the drugs or their ingredients used in this study.My organs are functioning well according to recent tests.I have HIV or Hepatitis B/C that is not under control.My side effects from previous cancer treatments are mild or gone.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Expansion with KEYTRUDA® (pembrolizumab)
- Group 2: Dose Escalation
- Group 3: Dose Expansion
- Group 4: Combination Expansion with Chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Dose Expansion a secure option for individuals?
"The safety rating for Dose Expansion is a 1 due to the Phase 1 trial status, indicating that there has been limited data gathered thus far regarding its efficacy and security."
Answered by AI
Are there any vacancies left for individuals to partake in this clinical exploration?
"As per the clinicaltrials.gov website, this medical trial is open for enrollment and was initially publicized on November 17th 2022. The protocol details have been revised as recently as 30th of November 20202."
Answered by AI
What is the current enrollment size of this study?
"Affirmative. Data hosted on clinicaltrials.gov shows that this medical study, which was initially posted on November 17th 2022, is currently seeking volunteers. Around 58 patients must be enrolled from a single research centre."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger