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Monoclonal Antibodies

Part 1 TPST-1120 for Oral Squamous Cell Carcinoma

Phase 1
Waitlist Available
Research Sponsored by Tempest Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Progressive disease or previously untreated tumors for which no standard therapy exists or treatment naïve at the time of study entry are eligible
Subjects with the following histologies are eligible and who are refractory to, have failed, are intolerant to, are ineligible for standard therapy, or for which no standard therapy exists are eligible: Part 1 (Dose Escalation- Monotherapy): RCC, NSCLC, CRC, metastatic castration resistant prostate cancer (mCRPC), cholangiocarcinoma, TNBC, pancreatic cancer, HCC, gastroesophageal cancer, squamous cell carcinoma of head and neck (SCCHN), urothelial bladder cancer (UBC), and sarcoma (liposarcomas and leiomyosarcomas); Part 2 (Dose Escalation-Combination with nivolumab): RCC, HCC, and cholangiocarcinoma; Part 3 (Dose Expansion-Monotherapy): RCC, HCC and cholangiocarcinoma; Part 4 (Dose Expansion-Combination with nivolumab): HCC.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment to end of treatment, up to 36 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug (TPST-1120) to see if it is safe and works well against tumors.

Eligible Conditions
  • Oral Squamous Cell Carcinoma
  • Non-Small Cell Lung Cancer
  • Gastroesophageal Cancer
  • Prostate Cancer
  • Bile Duct Cancer
  • Kidney Cancer
  • Bladder Cancer
  • Pancreatic Cancer
  • Liver Cancer
  • Squamous Cell Carcinoma
  • Breast Cancer
  • Colorectal Cancer
  • Sarcoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a tumor that is growing and cannot be treated with standard therapy, or you have not received any treatment for your tumor before.
Select...
You have certain types of cancer that have failed standard treatment or have no standard treatment options available. These include kidney, lung, colon, prostate, liver, breast, pancreatic, stomach, head and neck, bladder and certain types of sarcomas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment to end of treatment, up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to end of treatment, up to 36 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
Identify the maximum tolerated dose
Incidence of dose limiting toxicities (DLTs) of TPST-1120 as a single agent and in combination with nivolumab.
Incidence of treatment-emergent adverse events as assessed by NCI-CTCAE v5.0 of TPST-1120 as a single agent and in combination with nivolumab.
Secondary outcome measures
Assess pharmacokinetics: Area under the curve (AUC)
Assess pharmacokinetics: Maximum serum concentration (Cmax)
Objective response rate

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 4 TPST-1120 + nivolumabExperimental Treatment1 Intervention
Selected dose of TPST-1120 administered orally twice daily in combination with nivolumab administered intravenously every 28 days until MTD is reached for TPST-1120 or until disease progression
Group II: Part 3 TPST-1120Experimental Treatment1 Intervention
Selected dose of TPST-1120 administered orally twice daily until disease progression
Group III: Part 2 TPST-1120 + nivolumabExperimental Treatment1 Intervention
Subjects will receive escalating doses of TPST-1120 administered orally twice daily in combination with nivolumab administered intravenously every 28 days until MTD is reached for TPST-1120 or until disease progression.
Group IV: Part 1 TPST-1120Experimental Treatment1 Intervention
Subjects will receive escalating doses of TPST-1120 administered orally twice daily continuously until MTD is reached or until disease progression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Part 4 TPST-1120 + nivolumab
2019
Completed Phase 1
~40
Part 2 TPST-1120 + nivolumab
2019
Completed Phase 1
~40
Part 1 TPST-1120
2019
Completed Phase 1
~40
Part 3 TPST-1120
2019
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Tempest TherapeuticsLead Sponsor
2 Previous Clinical Trials
575 Total Patients Enrolled
Robert Stagg, PharmDStudy DirectorTempest Therapeutics

Frequently Asked Questions

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

For what health concerns is Part 1 TPST-1120 typically prescribed?

"Part 1 TPST-1120 is frequently used to combat malignant neoplasms, as well as other conditions such as metastatic esophageal adenocarcinoma and unresectable melanoma or squamous cell carcinoma."

Answered by AI

Does this research initiative represent a pioneering endeavor?

"Since 2012, Part 1 TPST-1120 has been the subject of an ongoing exploration. Ono Pharmaceutical Co. Ltd was responsible for its initial clinical trial in 2012, which concluded with 659 participants and subsequently granted Phase 1 & 2 drug approval. At present, 717 live studies exist across 2356 cities and 49 nations worldwide."

Answered by AI

Has the regulatory agency sanctioned TPST-1120 Part 1?

"Despite limited clinical evidence, Part 1 TPST-1120 is believed to be relatively safe and was thus assigned a score of 1."

Answered by AI

Are there any other experiments that have utilized Part 1 TPST-1120?

"The first trial of Part 1 TPST-1120 began in 2012 at Local Institution. 250 studies have since been completed, and 717 more are currently active - the majority hosted out of Ann Arbor, Michigan."

Answered by AI

How many participants are being treated in this therapeutic research study?

"Unfortunately, this trial is not presently recruiting. It was first posted on March 20th 2019 and updated for the last time November 1st 2022. If you are looking for alternative studies, there are currently 4723 ongoing clinical trials focussed on cholangiocarcinoma and 717 Part 1 TPST-1120 research projects in search of participants."

Answered by AI

How many medical establishments are conducting this experiment?

"The University of Michigan Rogel Cancer Center in Ann Arbor, the UPMC Hillman Cancer Centre in Pittsburgh, and the University of California - San Francisco are all participating sites for this medical trial. Additionally, there are 11 other locations hosting this clinical research."

Answered by AI

Is enrollment still open for this experimental research?

"This clinical trial is no longer taking on new participants. The study was posted in March of 2019 and last updated November 1st 2022, but if you are looking for other research options there are 4723 trials with cholangiocarcinoma actively recruiting patients as well as 717 Part 1 TPST-1120 studies enrolling volunteers."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
~6 spots leftby Mar 2025