Solid Tumor, AdultPhase 1NCT06507306
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
A Phase 1 study testing KQB198, Osimertinib and Amivantamab in people with Solid Tumor, Adult, run by Kumquat Biosciences Inc. at 26 sites in 4 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- KQB198, Osimertinib and Amivantamab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 26 sitesin 4 countries
- Study dates
- 3 Jun 2024to 31 Jan 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
Spain10 sites
Hospital Universitari Quiron Dexeus Barcelona
Barcelona, Catalonia, 08028
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, 08035
New Experimental Therapeutics (NEXT) Oncology Barcelona
Barcelona, 08023
South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
Barcelona, 08023
Hospital Universitario Ramon y Cajal
Madrid, 28034
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
Madrid, 28040
New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid
Madrid, 28223
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid
Hospital Quirónsalud Málaga
Málaga, 29004
Clinica Universidad de Navarra - Pamplona
Pamplona, 31008
United States9 sites
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Henry Ford Health System
Detroit, Michigan, 48202
New Experimental Therapeutics of Virginia - NEXT Oncology
Fairfax, Virginia, 22031
David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center
Long Island City, New York, 11101
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, 37203
Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -
Orlando, Florida, 32827
New Experimental Therapeutics of San Antonio - NEXT Oncology
San Antonio, Texas, 78229
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232
France5 sites
CHU Bordeaux - Hopital Saint-Andre
Bordeaux, Nouvelle-Aquitane, 33000
Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône, 13009
CHU de Nantes - Hopital Nord Laennec
Nantes, Pays de la Loire Region, 44000
Institut de Cancerologie de l'Ouest - site St-Herblain
Saint-Herblain, Loire-Atlantique, 44800
IUCT-Oncopole
Toulouse, Occitaine, 31059
Italy2 sites
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples, 80131
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, Lazio, 00168
About this study
Official title: A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB198 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies
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
- Conditions
- Solid Tumor, Adult
- Being tested
- KQB198, Osimertinib, Amivantamab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KQB198Drug
Oral KQB198
OsimertinibDrug
Also called Tagrisso
Oral Osimertinib
AmivantamabDrug
Subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Not described Receives: Drug: KQB198 |
| Combo Therapy Dose Escalation | Experimental | Not described Receives: Drug: KQB198; Drug: Osimertinib; Drug: Amivantamab |
| Combo Therapy Dose Expansion - RP2D | Experimental | Not described Receives: Drug: KQB198; Drug: Osimertinib; Drug: Amivantamab |
| Combo Therapy Dose Expansion - RP2D-1 | Experimental | Not described Receives: Drug: KQB198; Drug: Osimertinib; Drug: Amivantamab |
| Combo Therapy Dose Expansion OBD | Experimental | Not described Receives: Drug: KQB198; Drug: Osimertinib; Drug: Amivantamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)
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 28 days after last dose of study treatment.
Measured: 28 Days
Recommended Phase 2 Dose (RP2D) (Part 1)
Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.
Measured: up to 30 months
Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3)
Objective response 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.
Measured: up to 30 months
Secondary outcomes (8)
Concentration-time curve (AUC)
Measured: up to 30 months
Maximum plasma concentration (Cmax)
Measured: up to 30 months
Time to maximum plasma concentration (tmax)
Measured: up to 30 months
Overall survival (OS)
Measured: up to 30 months
Progression-free survival (PFS)
Measured: up to 30 months
Overall response rate (ORR)
Measured: up to 30 months
Duration of response (DOR)
Measured: up to 30 months
Time to response (TTR)
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start3 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumquat Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507306
- Sponsor's protocol ID
- KQB198-101
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No