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

Summary

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198? * Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198. * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

Eligibility

Inclusion Criteria:

* PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
* PART 1 (combo therapy with Cetuximab) \& 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
* Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts

Conditions5

Interventions3

Locations11 sites

Find trials near these locations

Related trials

• A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer — Tianjin Medical University Cancer Institute and Hospital
• A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers — Hummingbird Bioscience
• A Study of BND-35 in Participants With Advanced Solid Tumors — Biond Biologics
• A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent/MetastaticHead and Neck Squamous Cell Carcinoma Cancer — Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• AK129 Combination Therapy for Advanced Solid Tumors — Akeso
• ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors — Hansoh BioMedical R&D Company
• BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment — Pierre Fabre Pharma GmbH
• Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study — Sun Yat-sen University

Browse More Trials