A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Launched by KUMQUAT BIOSCIENCES INC. · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called KQB365 for adults with advanced solid tumors, particularly those with specific mutations known as KRAS G12C or KRAS G12S. The main goals are to find out how safe KQB365 is, determine the best dose to use, and see if it can help shrink tumors either on its own or when combined with another medication called cetuximab. Participants will receive KQB365 through an infusion once a week and will need to visit the clinic around nine times in the first six weeks for monitoring and assessments.

To be eligible for this study, participants need to have a confirmed diagnosis of certain types of solid tumors, particularly colorectal cancer, that have not responded to other treatments and cannot be surgically removed. Those interested should have good overall health and measurable cancer. However, individuals with active brain tumors, certain heart problems, or lung diseases would not qualify. Overall, this trial offers a potential new option for patients with limited treatment choices.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • PART 1 (monotherapy): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
• • PART 1 (combo therapy) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.
• • Unresectable or metastatic disease
• • No available treatment with curative intent
• • Adequate organ function
• • Measurable disease per RECIST v1.1
• Exclusion Criteria:
• • Active primary central nervous system tumors
• • Cardiac abnormalities
• • Active interstitial lung disease