JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration

NCT06973564
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
344
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Lead sponsor
Jacobio Pharmaceuticals Co., Ltd.
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Start date
2025-05-29
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Number of sites
4
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Summary
This study is to evaluate the safety and tolerability of pan-KRAS inhibitor JAB-23E73 Monotherapy and in Combination with Other Agents in adult participants with advanced solid tumors
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Short title
JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration
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Official title
A Phase 1/2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JAB-23E73 Monotherapy and in Combination With Other Agents in Adult Patients With Advanced Solid Tumors With KRAS Alteration
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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/Phase 2
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Study type
Interventional
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Completion date
2029-02-01
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First posted
2025-05-15
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Registry last updated
2026-10-26
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Primary completion date
2028-11-01
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Start date
2025-05-29
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Participants
344
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Participant count basis
Estimated
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Planned participants
344
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Protocol amendments
3
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Number of sites
4
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Registry sponsor category
Industry
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Lead sponsor
Jacobio Pharmaceuticals Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06973564
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ClinicalTrials.gov ID
NCT06973564
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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
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  1. Part A: Number and proportion of patients who experience at least 1 dose-limiting toxicity (DLT) with treatment of JAB-23E73 monotherapy.

    Timeframe: Up to 1 year

    A DLT is defined as any toxicities that meet the criteria for a DLT defined in the protocol

  2. Part A: Safety and tolerability of JAB-23E73 monotherapy

    Timeframe: Up to 2 years

    Incidence, and severity of adverse events and changes in clinical laboratory tests and examinations.

  3. Part A: Objective response rate (ORR) of JAB-23E73 monotherapy.

    Timeframe: Up to 3 years

    ORR, defined as the percentage of patients with the best overall response of confirmed partial response (PR), or complete response (CR) per RECIST v1.1.

  4. Part B1: Safety, tolerability and RP2D of JAB-23E73 in combination with cetuximab.

    Timeframe: Up to 2 years

    Incidence, and severity of adverse events and changes in clinical laboratory tests and examinations. RP2D will be determined based on comprehensive available data

  5. Part B1: Objective response rate (ORR) of JAB-23E73 in combination with cetuximab.

    Timeframe: Up to 3 years

    ORR, defined as the percentage of patients with the best overall response of confirmed PR, or CR per RECIST v1.1.

  1. Part A: DOR, TTR, PFS, and DCR assessed by investigators, and OS of JAB-23E73 monotherapy

    Timeframe: Up to 3 years

    Assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  2. Part A: Pharmacokinetic (PK) profile of JAB-23E73 monotherapy

    Timeframe: Up to 2 years

    Maximum Observed Concentration (Cmax), time to reach maximum concentration (Tmax), and area under the plasma concentration-time curve (AUC), etc

  3. Part B1: DOR, TTR, PFS, and DCR assessed by investigators, and OS of JAB-23E73 in combination with cetuximab

    Timeframe: Up to 3 years

    Assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  4. Part B1: PK profile of JAB-23E73 in combination with cetuximab.

    Timeframe: Up to 2 years

    The plasma concentration and PK parameters of JAB-23E73, including but not limited to: Cmax, AUC, and Ctrough.

Sources for outcomes
clinicaltrials.gov

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

  • Written informed consent.
  • Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
  • Histologically or cytologically confirmed locally advanced or metastatic solid tumors that are not suitable for curative interventions and who have received relevant prior systemic therapy.(Part A)
  • Histologically/cytologically confirmed unresectable locally advanced or metastatic CRC who progressed on or were intolerant to ≥1 standard systemic regimen with fluorouracil derivatives, oxaliplatin, irinotecan, FDA-approved immunotherapy or targeted therapies.(Part B1 only)
  • Patients must have KRAS alterations.
  • Participants are required to provide an archived tumor sample.
  • Patients with a life expectancy ≥3 months.
  • ECOG performance status score of 0 or 1.
  • Patients must have at least one measurable lesion as defined by RECIST v1.1.

  • Inability to swallow oral medications, or presence of gastrointestinal dysfunction or gastrointestinal disorders that may significantly alter the absorption of the study drug.
  • Patients who have previously been treated with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-RAS/pan-KRAS/multi-KRAS inhibitors, or similar agents.
  • Participants who have previously been treated with cetuximab or other EGFR antibodies (Part B1 only).
  • Known serious allergy to JAB-23E73 or excipient.
  • Patients with primary central nervous system tumors.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures or medical intervention.
  • QT interval>470 msec.
  • LVEF ≤50% assessed by ECHO or MUGA.
Sources for eligibility
clinicaltrials.gov

  • Mayo ClinicRochester, United StatesRecruiting
  • Washington UniversitySt Louis, United StatesRecruiting
  • Cleveland Clinic FoundationCleveland, United StatesRecruiting
  • Huntsman Cancer InstituteSalt Lake City, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (2)

Targets (1)