TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers
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ClinicalTrials.gov Identifier: NCT03829436 |
Recruitment Status :
Completed
First Posted : February 4, 2019
Last Update Posted : July 3, 2023
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Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma Metastatic Castration Resistant Prostate Cancer Renal Cell Carcinoma Non-small Cell Lung Cancer Colorectal Cancer Squamous Cell Carcinoma of Head and Neck Triple-Negative Breast Cancer Urothelial Carcinoma Cholangiocarcinoma GastroEsophageal Cancer Pancreatic Cancer Sarcoma | Drug: Part 1 TPST-1120 Drug: Part 2 TPST-1120 + nivolumab Drug: Part 3 TPST-1120 Drug: Part 4 TPST-1120 + nivolumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/1b Open-label, Dose-escalation and Dose-expansion Study of TPST-1120 as a Single Agent or in Combination With Systemic Anti-Cancer Therapies in Subjects With Advanced Solid Tumors |
Actual Study Start Date : | March 20, 2019 |
Actual Primary Completion Date : | September 7, 2022 |
Actual Study Completion Date : | September 7, 2022 |
Arm | Intervention/treatment |
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Experimental: Part 1 TPST-1120
Subjects will receive escalating doses of TPST-1120 administered orally twice daily continuously until MTD is reached or until disease progression
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Drug: Part 1 TPST-1120
Subjects will receive escalating doses of TPST-1120 administered orally twice daily continuously until MTD is reached or until disease progression
Other Name: Experimental |
Experimental: Part 2 TPST-1120 + nivolumab
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.
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Drug: Part 2 TPST-1120 + nivolumab
Subjects will receive escalating doses of TPST-1120 administered orally twice daily
Other Name: Experimental + Opdivo |
Experimental: Part 3 TPST-1120
Selected dose of TPST-1120 administered orally twice daily until disease progression
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Drug: Part 3 TPST-1120
Selected dose of TPST-1120 administered orally twice daily until disease progression
Other Name: Experimental |
Experimental: Part 4 TPST-1120 + nivolumab
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
|
Drug: Part 4 TPST-1120 + nivolumab
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
Other Name: Experimental + Opdivo |
- Incidence of dose limiting toxicities (DLTs) of TPST-1120 as a single agent and in combination with nivolumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]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. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]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.
- Identify the maximum tolerated dose [ Time Frame: From start of treatment to end of treatment, up to 36 months ]Incidence of dose limiting toxicities (DLTs) of TPST-1120 as a single agent and in combination with nivolumab.
- Assess pharmacokinetics: Maximum serum concentration (Cmax) [ Time Frame: Day 1, 2, 8 of Cycle 1 and Day 1 of Cycle 3 (cycle can be 21 or 28 days, depending on cohort assignment) ]Maximum serum concentration (Cmax) of TPST-1120
- Assess pharmacokinetics: Area under the curve (AUC) [ Time Frame: Day 1, 2, 8 of Cycle 1 and Day 1 of Cycle 3, Day 1 of Cycles 5+ (cycle can be 21 or 28 days, depending on cohort assignment) ]Area under the curve (AUC) of TPST-1120
- Objective response rate [ Time Frame: From start of treatment to end of treatment, up to 36 months ]Objective response rate per RECIST v1.1 criterion of TPST-1120 as a single agent and in combination with nivolumab.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Eastern Cooperative Oncology Group performance status of 0-1 at enrollment
- Progressive disease or previously untreated tumors for which no standard therapy exists or treatment naïve at the time of study entry are eligible
- Have at least one measurable lesion according to RECIST v1.1
- 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.
Exclusion Criteria
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, a specimen-collection study or the follow-up period of an interventional study
- Any chemotherapy, monoclonal antibody therapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment within 28 days of commencing TPST-1120 treatment. Targeted therapy such as tyrosine kinase inhibitors within 14 days of commencing first dose of study drug(s)
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For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA4 therapy:
- Subjects must not have experienced an irAE toxicity that led to permanent discontinuation of prior immunotherapy.
- Any unresolved irAE > Grade 1 with prior immunotherapy treatment.
- Symptomatic, untreated or actively progressing central nervous system metastases
- Have received fibrates within 28 days before first dose of investigational agent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829436
United States, California | |
University of California - San Francisco | |
San Francisco, California, United States, 94158 | |
United States, Florida | |
Miami Cancer Institute | |
Miami, Florida, United States, 33176 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Michigan | |
University of Michigan Rogel Cancer Center | |
Ann Arbor, Michigan, United States, 48109 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10024 | |
United States, North Carolina | |
Carolina BioOncology Institute | |
Huntersville, North Carolina, United States, 28078 | |
United States, Oklahoma | |
Stephenson Cancer Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Pennsylvania | |
University of Pennsylvania Perelman School of Medicine | |
Philadelphia, Pennsylvania, United States, 19104 | |
Thomas Jefferson University Hospital | |
Philadelphia, Pennsylvania, United States, 19107 | |
UPMC Hillman Cancer Center | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
Sarah Cannon Research Institute - TN | |
Nashville, Tennessee, United States, 37203 |
Study Director: | Robert Stagg, PharmD | Tempest Therapeutics |
Responsible Party: | Tempest Therapeutics |
ClinicalTrials.gov Identifier: | NCT03829436 |
Other Study ID Numbers: |
TPST-1120-001 |
First Posted: | February 4, 2019 Key Record Dates |
Last Update Posted: | July 3, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Carcinoma, Renal Cell Triple Negative Breast Neoplasms Cholangiocarcinoma Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urogenital Neoplasms Neoplasms by Site Urogenital Diseases Male Urogenital Diseases Carcinoma, Squamous Cell Adenocarcinoma Kidney Neoplasms |
Urologic Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Urologic Diseases Breast Neoplasms Breast Diseases Skin Diseases Head and Neck Neoplasms Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |