A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Kumquat Biosciences Inc.

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor, Adult

Treatments: Drug: Osimertinib; Drug: Amivantamab; Drug: KQB198

Study type: Interventional

Funder types: Industry

Identifiers

NCT06507306

KQB198-101

Details and patient eligibility

About

The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are:

• What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs?
• Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor?
• What happens to KQB198 in the body?

Participants will:

• Take KQB198 daily, alone or in combination with another anti-cancer drug
• Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PART 1 - Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations: EGFR, RAS, PTPN11, or SOS1 mutations, or inactivating mutations of NF1.
• PART 1 - (Osimertinib and Amivantamab arms) and Part 2 Cohort A and Cohort B: Histologically confirmed diagnosis of NSCLC with activating EGFR mutation and progression on osimertinib
• Part 3 - Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation
• Unresectable or metastatic disease
• No available treatment with curative intent
• Adequate organ function
• Measurable disease per RECIST 1.1.

Exclusion criteria

• Prior therapy with a similar mechanism of action to KQB198
• History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
• History of interstitial lung disease
• Cardiac abnormalities

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 5 patient groups

Monotherapy Dose Escalation

Experimental group

Treatment:

Drug: KQB198

Combo Therapy Dose Escalation

Experimental group

Treatment:

Drug: KQB198

Drug: Amivantamab

Drug: Osimertinib

Combo Therapy Dose Expansion - RP2D

Experimental group

Treatment:

Drug: KQB198

Drug: Amivantamab

Drug: Osimertinib

Combo Therapy Dose Expansion - RP2D-1

Experimental group

Treatment:

Drug: KQB198

Drug: Amivantamab

Drug: Osimertinib

Combo Therapy Dose Expansion OBD

Experimental group

Treatment:

Drug: KQB198

Drug: Amivantamab

Drug: Osimertinib