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OncoMatch/Clinical Trials/NCT04999761

AB122 Platform Study

Is NCT04999761 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments for advanced or metastatic solid tumor.

Phase 1RecruitingTaiho Pharmaceutical Co., Ltd.NCT04999761Data as of Sep 2026Location: Japan

Treatment: AB122 · TAS-116 · TAS-120 · TAS-115 · TAS-102 · Ramucirumab · Bevacizumab · Fluorouracil · Cisplatin · AB154 · Carboplatin · nab-Paclitaxel · GemcitabineThis is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

RamucirumabBevacizumab

Chemotherapy

FluorouracilCisplatinCarboplatinnab-PaclitaxelGemcitabine

Other

AB122TAS-116TAS-120TAS-115TAS-102AB154

Cancer type

Tumor Agnostic

Pancreatic Cancer

Colorectal Cancer

Non-Small Cell Lung Carcinoma

Gastric Cancer

Sarcoma

Esophageal Carcinoma

Head and Neck Squamous Cell Carcinoma

Cholangiocarcinoma

Biomarker criteria

Required: PD-L1 (CD274) overexpression (≥ 50% tumor proportion score)

Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory.

Required: PD-L1 (CD274) overexpression (≥ 50% tumor proportion score)

Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory (except for tolerability part).

Required: KRAS wild-type

RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy; Wild type is defined as v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) (exon 2, 3 and 4) and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) (exon 2, 3 and 4) wild type.

Required: NRAS wild-type

RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy; Wild type is defined as v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) (exon 2, 3 and 4) and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) (exon 2, 3 and 4) wild type.

Performance status

ECOG 0–1(Restricted strenuous activity)

ECOG performance status (PS) of 0 or 1 before administration of study treatment

Prior therapy

Must have received: systemic chemotherapy — advanced or metastatic PDAC

Has disease progression after or intolerant to one prior systemic chemotherapy for advanced or metastatic disease

Must have received: systemic chemotherapy — advanced or metastatic CRC

Has been received one regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the chemotherapy

Must have received: systemic chemotherapy — advanced or metastatic non-squamous NSCLC

Has been received one or two regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the standard treatment

Must have received: immune checkpoint inhibitor (anti PD-1 antibodies, anti PD-L1 antibodies, anti CTLA-4 antibodies) — advanced or metastatic non-squamous NSCLC

Has been most recently received regimen including an ICI (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies) and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotherapy followed by checkpoint inhibitor therapy), and all of the following criteria must be met: Received at least 2 doses at the most recent ICI therapy; Radiographic complete response or partial response based on investigator assessment with ICI therapy; Documented radiographic disease progression with above most recently received regimen

Must have received: systemic chemotherapy — advanced or metastatic gastric or gastroesophageal junction cancer

Has received 2-4 standard regimens listed below and has demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose

Must have received: systemic chemotherapy (fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF monoclonal antibody) — advanced CRC

Prior treatment regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody

Must have received: anti-EGFR monoclonal antibody — advanced CRC, RAS wild-type

For RAS wild-type patients, an anti-EGFR monoclonal antibody must have included in addition to above

Must have received: immune checkpoint inhibitor (anti PD-1 antibodies, anti PD-L1 antibodies, anti CTLA-4 antibodies) — advanced or metastatic NSCLC

Has been received one regimen of ICI monotherapy or combination therapy (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies), and all of the following criteria must be met: Received at least 2 doses of the ICI therapy; Documented radiographic disease progression with or after ICI therapy

Cannot have received: immune checkpoint inhibitor (anti-PD-L1, anti-PD-1, anti-CTLA-4)

Exception: except for cohort B-3, C-1, D-1 tolerability part and E-1

Prior treatment with an anti-PD-L1 anti-PD-1, anti-CTLA-4, or other ICI or agonist as monotherapy or in combination (except for cohort B-3, C-1, D-1 tolerability part and E-1).

Lab requirements

Blood counts

ANC ≥ 1500 /mm3; Platelet count ≥ 100000 /mm3; Hemoglobin value of ≥ 9.0 g/dL

Kidney function

Known severe chronic kidney disease [excluded]

Liver function

AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN; T-Bil of ≤ 1.5 × ULN

Cardiac function

Clinically significant history or current evidence of cardiac arrhythmia and/or conduction abnormality; Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (NYHA class III or IV) within the previous 6 months

Has adequate organ function as defined by the following criteria: AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN; T-Bil of ≤ 1.5 × ULN; ANC ≥ 1500 /mm3; Platelet count ≥ 100000 /mm3; Hemoglobin value of ≥ 9.0 g/dL

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT04999761 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior immune checkpoint inhibitor disqualifies patients from enrollment.

Does this trial require CD274?

Yes, CD274 overexpression is a required biomarker for enrollment.

Does this trial require CD274?

Yes, CD274 overexpression is a required biomarker for enrollment.

Does this trial require KRAS?

Yes, KRAS wild-type is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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