ClinicalTrials.gg
RecruitingNCT06959615Updated Jan 20, 2026

A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration

A Phase 1/2 interventional study of JAB-23E73 and JAB-23E73 in Advanced Solid Tumor, sponsored by Jacobio Pharmaceuticals Co., Ltd.. Recruiting at 32 sites in China. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Jacobio Pharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2024, registered Apr 2025).
  • Started Nov 2024; still recruiting 1 year 11 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1/2
Study type
Interventional
Enrollment
334
Allocation
Non-randomized
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 629 studies in Pancreatic Neoplasms with a site in China — 334 open to participants now, 359 under way, 30 of them phase 3. Pancreatic Neoplasms · China.

Planned enrollment
54th of 507
334 · median 58
Started
2024
with 107 others
Phase 1/2
79 of 629
46 open now
Primary completion
2026-12
later than 181 of 358 live
Registered
510th of 629
by date

Among the 629 studies in Pancreatic Neoplasms with a site in China, this one is the 54th largest by planned enrollment of the 507 interventional ones that give a count, is one of 108 that started in 2024, is one of 79 in phase 1/2, reaches primary completion later than 181 of the 358 other live ones, and was the 510th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

334 of the 629 studies in Pancreatic Neoplasms with a site in China are open now. Recruiting first, the newest first:

329 more — sign in →

All 334 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 629 studies in Pancreatic Neoplasms with a site in China, or all of them as a file.
02

Study summary

This is a multicenter, open-label, phase I/IIa to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of pan-KRAS inhibitor JAB-23E73 in patients with advanced solid tumors harboring KRAS mutations or amplification. The study consists of 2 phases: Phase 1 Dose Escalation and Phase IIa Dose Expansion.

Read the detailed description

Study JAB-23E73-1001 is a global multicenter, open-label Phase 1/2a study to 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. This study consists of a Phase 1a dose-escalation, followed by Phase 1b dose-expansion (dose optimization) and Phase 2a indication expansion. After completing dose-escalation, the MTD or preliminary RP2D of JAB-23E73 will be determined. Then, two of the alternative dosages of JAB-23E73 will be selected to further evaluate the efficacy, safety and PK in patients with KRAS-alternated NSCLC or other tumors, and patients may be further selected by certain/several types of KRAS-alternations based on dose escalation data. The RP2D will be determined according to the safety, efficacy and PK data from phase 1b.

03

Conditions studied

  • Advanced Solid Tumor

Keywords

  • KRAS
  • KRAS mutation
  • KRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A, KRAS G12D
  • Pan-KRAS
  • NSCLC
  • Pancreas cancer
  • Colorectal cancer
  • KRAS-mutant tumor
  • Targeted Therapy
  • JAB-23E73
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Histological or proven diagnosis of a locally advanced, unresectable, and/or solid tumor cancer with evidence of KRAS gene alteration (including gene mutation and wild type amplification).
  2. Able to provide an archived tumor tissue sample or fresh sample.
  3. ≥3 months at the start of treatment.
  4. (ECOG) performance status of 0 or 1.
  5. ≥1 per v1.1.
  6. Adequate organ function.

Exclusion criteria

Exclusion Criteria:

  1. Unable to swallow oral medications or with gastrointestinal dysfunction or gastrointestinal disease that significantly alters the absorption of medication.
  2. Previous treatment with rat sarcoma (RAS) targeting agents.
  3. Symptomatic, untreated, or actively progressing known central nervous system (CNS) .
  4. Impaired cardiovascular function or cardiac disease.
  5. Mean corrected using Fridericia's formula (QTcF) >470 msec.
  6. Females who are pregnant or breastfeeding.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
334 participants (estimated)

Study arms

  • Experimental
    Phase 1 Dose Exploration

    Monotherapy, dose escalation

    Drug: JAB-23E73

  • Experimental
    Phase 2a Dose Expansion

    Monotherapy, dose expansion

    Drug: JAB-23E73

Interventions

  • DrugJAB-23E73

    Administered orally

  • DrugJAB-23E73

    Administered orally

06

What researchers measure

Primary outcomes

  1. Phase 1: Number of participants with dose limiting toxicities (DLT)

    Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.

    Time frame: Up to 21 days

  2. Phase 2a: Objective response rate (ORR)

    ORR is defined as the proportion of patients with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1.

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Phase 1/2a: Adverse events

    Incidence and severity of treatment-emergent Adverse Events (TEAEs), treatment-related Adverse Events (TRAEs) and serious Adverse Events (SAEs)

    Time frame: Up to approximately 2 years

  2. Phase 1/2a: Pharmacokinetic (PK): Maximum concentration (Cmax) of JAB-23E73

    PK: Cmax of JAB-23E73

    Time frame: Up to approximately 2 years

  3. Phase 1/2a: PK: Time to Maximum Concentration (Tmax) of JAB-23E73

    PK: Tmax of JAB-23E73

    Time frame: Up to approximately 2 years

  4. Phase 1/2a: PK: Area Under the Concentration Versus Time Curve (AUC) of JAB-23E73

    PK: AUC of JAB-23E73

    Time frame: Up to approximately 2 years

  5. Phase 1: ORR

    ORR is defined as the proportion of patients with a BOR of confirmed CR or confirmed PR per RECIST v1.1.

    Time frame: Up to approximately 2 years

  6. Phase 1/2a: Time to Response (TTR)

    TTR is defined as the time from the date of first dose of study drug to first documentation of response as assessed by the investigator per RECIST v1.1

    Time frame: Up to approximately 2 years

  7. Phase 1/2a: Progression Free Survival (PFS)

    PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of progressive disease assessed by the investigator per RECIST v1.1 or death, whichever occurs first.

    Time frame: Up to approximately 2 years

  8. Phase 1/2a: Disease Control Rate (DCR)

    DCR is defined as the proportion of patients with CR, PR, or stable disease (SD) as assessed by the investigator per RECIST v1.1

    Time frame: Up to approximately 2 years

  9. Phase 1/2a: Duration of Response (DoR)

    DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.

    Time frame: Up to approximately 2 years

  10. Phase 2a: Overall Survival (OS)

    OS is defined as the time from the date of first dose of study drug until the date of death from any cause.

    Time frame: Up to approximately 2 years

07

Study locations

17 of 32 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Dec 2026, 25 months after the start.

Of 115 industry-sponsored phase 1/2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 88. This study's planned 25 months is below that.

Counting every sponsor, half of 209 studies reached it within 51 months; a quarter within 36 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2025
First posted
May 6, 2025
StartActual
Nov 22, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Aug 31, 2027
Last update
Jan 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06959615
Lead sponsor
Jacobio Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
May 6, 2025
Start date
Nov 22, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Jan 20, 2026

Study contacts

Jacobio Pharmaceuticals
Contact
clinicaltrials@jacobiopharma.com
86 10 56315466

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion