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Advanced Solid TumorsPhase 1/2NCT06973564

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

A Phase 1/2 study testing JAB-23E73 and Cetuximab in people with Advanced Solid Tumors, run by Jacobio Pharmaceuticals Co., Ltd. at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
JAB-23E73 and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
344 participants
Where
4 sitesUnited States
Study dates
29 May 2025to Feb 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jacobio Pharmaceuticals contact

(781) 918-6670

clinicaltrials@jacobiopharma.com

United States4 sites, 4 recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

About this study

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

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

Read the detailed description

This is a multi-part, open-label, multi-center Phase 1/2a study evaluating JAB-23E73 as monotherapy (Part A) and in combination with other agents (Part B1: with cetuximab) in adult participants with advanced solid tumors.

Part A will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anticancer activity of JAB-23E73 as a single agent in adult patients with advanced solid tumors with KRAS alteration. Part A consists of three phases: Phase 1a dose-escalation, Phase 1b dose expansion (dose optimization), and Phase 2a indication expansion.

Part B1 will evaluate the safety, tolerability, PK, PDc, and preliminary anti-tumor efficacy of JAB-23E73 combined with cetuximab in adult participants with locally advanced or metastatic KRAS-altered CRC. Part B1 consists of two phases: Phase 1b dose escalation phase and Phase 2a dose expansion phase.

Being tested
JAB-23E73, Cetuximab
Keywords
KRAS, KRAS mutation, KRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A, KRAS G12D, Pan-KRAS, Targeted Therapy, NSCLC, Pancreas cancer, Colorectal cancer, KRAS-mutant tumor, JAB-23E73, Cetuximab
Medical subject headings
Pancreatic Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JAB-23E73Drug

    Oral administration

  • CetuximabDrug

    Intravenous infusion

Study groups in NCT06973564
Study groupRoleWhat they receive
Part AExperimentalJAB-23E73 monotherapy.
Receives: Drug: JAB-23E73
Part B1ExperimentalJAB-23E73 combined with cetuximab
Receives: Drug: JAB-23E73; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number and proportion of patients who experience at least 1 dose-limiting toxicity (DLT) with treatment of JAB-23E73 monotherapy.

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

    Measured: Up to 1 year

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

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

    Measured: Up to 2 years

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

    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.

    Measured: Up to 3 years

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

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

    Measured: Up to 2 years

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

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

    Measured: Up to 3 years

Secondary outcomes (4)

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

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

    Measured: Up to 3 years

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

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

    Measured: Up to 2 years

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

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

    Measured: Up to 3 years

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

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

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2025
  2. Study start29 May 2025
  3. Primary completionNov 2028 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
344 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06973564
Sponsor's protocol ID
JAB-23E73-1002
Status last verified
Oct 2026
First submitted
24 Apr 2025
Last updated
26 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JAB-23E73 and Cetuximab in people with Advanced Solid Tumors, run by Jacobio Pharmaceuticals Co., Ltd. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jacobio Pharmaceuticals ((781) 918-6670, clinicaltrials@jacobiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number and proportion of patients who experience at least 1 dose-limiting toxicity (DLT) with treatment of JAB-23E73 monotherapy. (time frame: Up to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06973564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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