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

Kumquat Biosciences Inc.

Status and phase: Enrolling; Phase 1

Conditions: KRAS G12C Mutation; Solid Tumor Malignancies; CRC (Colorectal Cancer); KRAS G12S Mutation

Treatments: Drug: KQB365; Drug: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06720987

KQB365-101

Details and patient eligibility

About

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 or in combination with cetuximab?
• Does KQB365 alone or in combination with cetuximab decrease the size of the tumor?
• What happens to KQB365 in the body?

Participants will:

• Receive KQB365 infusion weekly alone or in combination with cetuximab
• Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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128 participants in 6 patient groups

Monotherapy Dose Escalation

Experimental group

Description:

Drug: KQB365 - Intravenous KQB365

Treatment:

Drug: KQB365

Combo Therapy Dose Escalation

Experimental group

Description:

Drug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab

Treatment:

Drug: Cetuximab

Drug: KQB365

Monotherapy Dose Expansion - RP2D

Experimental group

Description:

Drug: KQB365 - Intravenous KQB365

Treatment:

Drug: KQB365

Monotherapy Dose Expansion - RP2D-1

Experimental group

Description:

Drug: KQB365 - Intravenous KQB365

Treatment:

Drug: KQB365

Combo Therapy Dose Expansion - RP2D

Experimental group

Description:

Drug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab

Treatment:

Drug: Cetuximab

Drug: KQB365

Combo Therapy Dose Expansion - RP2D-1

Experimental group

Description:

Drug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab

Treatment:

Drug: Cetuximab

Drug: KQB365