A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors
NCT06797336 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 115
Last updated 2025-12-18
Summary
The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0253 in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutated advanced solid tumors as monotherapy.
Conditions
Interventions
- DRUG
-
PT0253
PT0253 injection.
Sponsors & Collaborators
-
PAQ Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-19
- Primary Completion
- 2026-12-15
- Completion
- 2027-06-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
NCT07020221 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study to Evaluate D-1553 in Subjects With Solid Tumors
NCT04585035 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
GH35 Tablets for Advanced Solid Tumors: A Study on Safety and Early Results
NCT05010694 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study Of PF-06647263 In Patients With Advanced Solid Tumors
NCT02078752 ·Status: TERMINATED ·Phase: PHASE1
-
A First-in-Human Trial of Safety and Efficacy of GEN1078 in Participants With Solid Tumors
NCT06771921 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study of SY-5933 in Patients With Advanced Solid Tumors Harboring the KRAS p.G12C Mutation
NCT06006793 ·Status: UNKNOWN ·Phase: PHASE1
-
First-in-Human Study of JNJ-74699157 in Participants With Tumors Harboring the KRAS G12C Mutation
NCT04006301 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors
NCT06619587 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (Kirsten Rat Sarcoma Viral Oncogene Homologue [KRAS])
NCT04835714 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of PSB205 in Subjects With Advanced Solid Tumors
NCT03986606 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors
NCT03355066 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy With GenSci122 in Participants With Advanced Solid Tumors
NCT06772415 ·Status: RECRUITING ·Phase: PHASE1
-
Study of PKI-179 Administered Orally to Subjects With Solid Tumors
NCT00997360 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
NCT03600883 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase 1/2, Study of YL-15293 in Subjects With Advanced Solid Tumors With a KRAS G12C Mutation
NCT05119933 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors
NCT06403436 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors
NCT05283330 ·Status: RECRUITING ·Phase: PHASE1
-
QTX3046 in Patients With KRAS G12D Mutations
NCT06428500 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309
NCT01940133 ·Status: COMPLETED ·Phase: PHASE1
-
Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors
NCT07086768 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients
NCT00927823 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Participants with KRAS G12C Mutation Advanced Solid Tumors
NCT06594874 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
3D011-08 Monotherapy in Subjects With Advanced Solid Tumors
NCT05099536 ·Status: WITHDRAWN ·Phase: PHASE1
-
Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).
NCT06333951 ·Status: RECRUITING ·Phase: PHASE1
-
SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
NCT05480865 ·Status: TERMINATED ·Phase: PHASE1