Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06166836
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-12-04
Brief Title:
a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors
Sponsor:
InxMed Shanghai Co Ltd
Organization:
InxMed Shanghai Co Ltd
Study Overview
Official Title:
A Phase 1bII Open-label Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of D-1553 Combined With IN10018 in Subjects With Locally Advanced or Metastatic Solid Tumors With KRAS G12C Mutation
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 1bII open-label study to evaluate the safety tolerability pharmacokinetics and antitumor activities of D-1553 in combination with IN10018 in subjects with locally advanced or metastatic solid tumor with KRAS G12C mutation
Detailed Description:
This study includes 2 phases Phase Ib-Dose Escalation and Phase II-Dose Expansion Phase Ib-Dose Escalation part will enroll at least 6 subjects to identify the safety and RP2D of D1553 in combination with IN10018 in KRAS G12C mutant solid tumors Phase II-Dose Expansion part contains 3 cohorts with cohort A to enroll advanced colorectal cancer CRC with KRAS G12C mutation cohort B to enroll advanced non-small cell lung cancer NSCLC with KRAS G12C mutation and cohort C to enroll other advanced solid tumors with KRAS G12C mutation Phase II study is to evaluate the safety and antitumor activities of D-1553 in combination with IN10018 in KRAS G12C mutant solid tumors The sample size in each cohort is estimated per Simons 2-stage design In Cohort A when Simons 2-stage study achieved statistical hypothesis an open-label randomized study will be conducted for factorial analysis to evaluate the contribution of IN10018 in the combination regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None