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Monoclonal Antibodies

TPST-1495 + Pembrolizumab for Cancer

Phase 1
Recruiting
Research Sponsored by Tempest Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ and marrow function (subjects must not have received transfusions or growth factor support within 1 month prior to first dose of investigational product) as defined below:
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN; for subjects with liver metastases, AST or ALT ≤ 5 × ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment to treatment termination visit, up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, TPST-1495, to see if it is safe and effective in treating subjects with advanced solid tumors. The study will also look at the side effects of the drug and how it works in the body.

Who is the study for?
This trial is for adults with advanced solid tumors that are metastatic or unresectable, and no standard therapy remains. It's open to all solid tumor types but focuses on colorectal, head and neck squamous cell, urothelial, endometrial cancers, NSCLC, and gastric adenocarcinomas. Participants must have a life expectancy of at least 12 weeks, adequate organ function without recent transfusions or growth factors.Check my eligibility
What is being tested?
The study tests TPST-1495 alone or combined with Pembrolizumab in different doses/schedules to find the safest and most effective dose against various solid tumors. The first part determines the maximum tolerated dose; the second part expands testing to specific cancer types.See study design
What are the potential side effects?
Potential side effects include typical reactions from immune therapies such as fatigue, nausea, skin reactions. There may also be risks related to liver enzyme changes due to medication metabolism and possible immune-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs and bone marrow work well, and I haven't had transfusions or growth support in the last month.
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My liver enzymes are within the required limits.
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My tumor is at least 1 cm big and can be seen on a scan.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer cannot be surgically removed, has spread, and standard treatments have failed.
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My kidney function, measured by creatinine or its clearance, is within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment to treatment termination visit, up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to treatment termination visit, up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of maximum tolerated dose and/or recommended Phase 2 dose (RP2D) and optimum dose schedule for TPST-1495 as a single agent and in combination with pembrolizumab
Secondary outcome measures
Assess pharmacokinetics: Clearance (CL)
Assess pharmacokinetics: area under the serum concentration-time curve (AUC)
Assess pharmacokinetics: maximum serum concentration (Cmax)
+5 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

5Treatment groups
Experimental Treatment
Group I: TPST-1495 monotherapy dose expansionExperimental Treatment1 Intervention
Subjects will receive selected dose regimen from dose and schedule optimization stage until disease progression
Group II: TPST-1495 monotherapy dose escalationExperimental Treatment1 Intervention
Subjects will receive escalating doses of TPST-1495 administered orally twice daily until maximum tolerated dose is reached or until disease progression
Group III: TPST-1495 monotherapy dose and schedule optimizationExperimental Treatment1 Intervention
Subjects will receive alternative TPST-1495 administration schedules until RP2D for the selected schedule is determined or until disease progression.
Group IV: TPST-1495 in combination with pembrolizumab dose expansionExperimental Treatment2 Interventions
Subjects will receive selected dose regimen from dose and schedule optimization stage until disease progression
Group V: TPST-1495 in combination with pembrolizumab dose and schedule optimizationExperimental Treatment2 Interventions
Subjects will receive alternative TPST-1495 administration schedules in combination with pembrolizumab until RP2D for the selected schedule is determined or until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Tempest TherapeuticsLead Sponsor
2 Previous Clinical Trials
438 Total Patients Enrolled
Samuel Whiting, MD PhDStudy DirectorTempest Therapeutics

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04344795 — Phase 1
Oral Squamous Cell Carcinoma Research Study Groups: TPST-1495 in combination with pembrolizumab dose expansion, TPST-1495 monotherapy dose escalation, TPST-1495 monotherapy dose and schedule optimization, TPST-1495 monotherapy dose expansion, TPST-1495 in combination with pembrolizumab dose and schedule optimization
Oral Squamous Cell Carcinoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04344795 — Phase 1
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04344795 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is Pembrolizumab employed therapeutically?

"Pembrolizumab is typically utilized to treat malignant neoplasms, but it has also been prescribed for unresectable melanoma, microsatellite instability high cases and situations where chemotherapy fails."

Answered by AI

How many participants is the clinical trial seeking to recruit?

"The total number of participants necessary to run the trial is 175 and they must all meet the set inclusion criteria. Tempest Therapeutics will be hosting clinical trials at two sites: SCRI-OK Stephenson Cancer Center located in Oklahoma City, Oklahoma and South Texas Accelerated Research Therapeutics (START) based in San Antonio, Texas."

Answered by AI

Has Pembrolizumab been given the go-ahead by federal authorities?

"The safety of Pembrolizumab is rated as 1 due to its position in the clinical trial process; limited data exists that supports both efficacy and safety."

Answered by AI

Is this research currently open to participants?

"According to the most recent update on clinicaltrials.gov, this experiment is still searching for participants after being initially announced on May 6th 2020. The study was last updated 28 February 2022."

Answered by AI

Has Pembrolizumab been studied for other purposes beyond its current clinical trial?

"The initial research into pembrolizumab began in 2010 at the City of Hope. Since then, there have been 251 concluded studies and 961 active ones, many based out of Oklahoma City."

Answered by AI

Are there numerous medical centers conducting this clinical research in the state?

"Currently, enrolment is being accepted at 9 different sites across the United States. These locations include Oklahoma City, San Antonio and Philadelphia among other cities; thus minimising any inconvenience of travelling if you join this trial."

Answered by AI

What are the ultimate objectives of this clinical experiment?

"The primary objective of this clinical trial, which will span up to two years from the commencement of treatment and ending at termination visit is to accurately identify the maximum tolerated dose and/or recommended Phase 2 dosage (RP2D) as well as an optimal dosing schedule for TPST-1495 when used alone or in combination with pembrolizumab. Secondary objectives include assessing pharmacokinetics such as clearances (CL), recording any adverse events via NCI-CTCAE v.5.0, along with estimating preliminary efficacy by determining a duration of response (DoR)."

Answered by AI
~0 spots leftby Apr 2024