JAB-23E73 for Cancer

Recruiting at 3 trial locations

Overseen By Jacobio Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Must not be taking: KRAS inhibitors

Disqualifiers: CNS tumors, QT interval >470, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

294 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is to evaluate the safety and tolerability of JAB-23E73 in adult participants with advanced solid tumors

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that can't be cured by surgery or other treatments, who have specific changes in a gene called KRAS. They must have at least one tumor measurable by medical scans, expect to live more than 3 months, and be able to give consent. People with brain tumors, severe allergies to the study drug, heart issues, uncontrolled fluid buildup or those previously treated with similar drugs can't join.

Inclusion Criteria

Patients must have at least one measurable lesion as defined by RECIST v1.1

Participants are required to provide an archived tumor sample

Written informed consent

Exclusion Criteria

My cancer originated in the brain or spinal cord.

Known serious allergy to JAB-23E73 or excipient

QT interval >470 msec

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Phase 1a)

Evaluate overall safety, tolerability, and determine the maximum tolerated dose (MTD) of JAB-23E73 monotherapy

Up to 1 year

Dose Expansion / Optimization (Phase 1b)

Determine the recommended Phase 2 dose (RP2D) of JAB-23E73 in patients with KRAS-altered NSCLC or other selected tumors

Up to 2 years

Indication Expansion (Phase 2a)

Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JAB-23E73

Trial Overview The trial is testing JAB-23E73's safety and how well people tolerate it when given to adults with advanced solid tumors that have a KRAS alteration. The main goal is to see if this new treatment is safe and what effects it has on these types of cancers.

How Is the Trial Designed?

Group I: Indication Expansion (Phase 2a) Experimental Treatment 1 Intervention

Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors.

Group II: Dose Expansion / Optimization Phase (Phase 1b) Experimental Treatment 1 Intervention

Determine RP2D of JAB-23E73 in patients with KRAS-alternated NSCLC or other selected tumors

Group III: Dose Escalation (Phase 1a) Experimental Treatment 1 Intervention

Evaluate overall Safety, tolerability, and determine MTD of JAB-23E73 monotherapy.

Who Is Running the Clinical Trial?

Jacobio Pharmaceuticals Co., Ltd.

Lead Sponsor

Trials

21

Recruited

2,300+