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

NCT06720987
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
140
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Lead sponsor
Kumquat Biosciences Inc.
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Start date
2025-02-04
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Number of sites
11
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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.
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Short title
A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
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Official title
A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-06-30
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First posted
2024-12-06
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Registry last updated
2026-04-23
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Primary completion date
2029-06-30
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Start date
2025-02-04
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Participants
140
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Participant count basis
Estimated
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Planned participants
140
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Protocol amendments
3
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Number of sites
11
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Kumquat Biosciences Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06720987
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ClinicalTrials.gov ID
NCT06720987
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)

    Timeframe: From enrollment to the end of treatment

    Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 30 days after last dose of study treatment.

  2. Recommended Phase 2 Dose (RP2D) (Part 1)

    Timeframe: up to 35 months

    Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.

  3. Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Part 2)

    Timeframe: up to 35 months

    ORR is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.

  1. Concentration-time curve (AUC)

    Timeframe: up to 35 months

  2. Maximum plasma concentration (Cmax)

    Timeframe: up to 35 months

  3. Time to maximum plasma concentration (tmax)

    Timeframe: up to 35 months

  4. Overall survival (OS)

    Timeframe: up to 35 months

  5. Progression-free survival (PFS)

    Timeframe: up to 35 months

    using RECIST v1.1

  6. Overall response rate (ORR)

    Timeframe: up to 35 months

    using RECIST v1.1

  7. Duration of response (DOR)

    Timeframe: up to 35 months

    using RECIST v1.1

  8. Time to response (TTR)

    Timeframe: up to 35 months

    using RECIST v1.1

  9. Disease control rate (DCR)

    Timeframe: up to 35 months

    using RECIST v1.1

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Mayo Clinic, PhoenixPhoenix, United StatesRecruiting
  • Sarah Cannon Cancer Institute at HealthONEDenver, United StatesRecruiting
  • Mayo Clinic, JacksonvilleJacksonville, United StatesRecruiting
  • Dana Farber Cancer InstituteBoston, United StatesRecruiting
  • START MidwestGrand Rapids, United StatesRecruiting
  • Mayo Clinic, RochesterRochester, United StatesRecruiting
  • Cleveland Clinic, Taussig Cancer InstituteCleveland, United StatesRecruiting
  • OU Health Stephenson Cancer CenterOklahoma City, United StatesRecruiting
  • Sydney Kimmel Cancer CenterPhiladelphia, United StatesRecruiting
  • NEXT OncologySan Antonio, United StatesRecruiting
  • NEXT Virginia, LLCFairfax, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)

Targets (1)