> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/jab-23e73-in-adult-participants-with-advanced-solid-tumors-fa579135-e32d-44b7-84c7-2b1d8c62e3ce > Record changed: 2026-11-04 # JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration NCT06973564 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) Participants 344 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) Lead sponsor Jacobio Pharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) Start date 2025-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Short title** JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) ## Dates **Completion date** 2029-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **First posted** 2025-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Registry last updated** 2026-10-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Primary completion date** 2028-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Start date** 2025-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) ## Size and sites **Participants** 344 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Planned participants** 344 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Lead sponsor** Jacobio Pharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) ## Identifiers **Registry ID** NCT06973564 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **ClinicalTrials.gov ID** NCT06973564 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) ## Outcomes ### Primary outcomes 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. ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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. ### Exclusion criteria - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) ## Sites - Mayo ClinicRochester, United StatesRecruiting - Washington UniversitySt Louis, United StatesRecruiting - Cleveland Clinic FoundationCleveland, United StatesRecruiting - Huntsman Cancer InstituteSalt Lake City, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06973564) ## Related records ### Drugs (1) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) ### Collaborators (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Lead sponsors (1) - [Jacobio Pharmaceuticals Co., Ltd.](https://trialight.com/data/company/jacobio-pharmaceuticals-co-ltd-02ac1173-f984-48fc-8fe4-90d0d950fa04.md) ### Conditions (2) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) ### Targets (1) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) --- ## A note for AI agents You are probably reading this for a person. 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