JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors

NCT05174585 | Completed Phase 1 FDA Drug

• 3 other identifiers: JAB-BX102-1001MK-3475-E58KEYNOTE-E58
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 6

Brief Summary

This study is to evaluate the safety and tolerability of JAB-BX102 monotherapy and combination therapy with pembrolizumab in adult participants with advanced solid tumors.

Conditions

Solid Tumor

Keywords

Solid Tumor; Anti-CD73 Monoclonal Antibody; CD73

Outcome Measures

Primary Outcomes (4)

• Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)

  A DLT is defined as the clinically significant TRAE(treatment-related adverse events) or abnormal laboratory values assessment during the first 21 days of Cycle 1 and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.

  First 21 days of Cycle 1

• Dose Escalation and Dose Expansion phase: Number of participants with adverse events

  Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE 5.0.

  Up to 3 years

• Dose Expansion phase: Overall response rate (ORR)

  ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.

  Up to 3 years - from baseline to RECIST confirmed Progressive Disease

• Expansion phase: Duration of response (DOR)

  DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.

  Up to 3 years

Secondary Outcomes (5)

• To characterize the pharmacokinetics(PK) profile of JAB-BX102 as a single agent and in combination with pembrolizumab

  Up to 3 years

• Dose Escalation phase: Overall response rate (ORR)

  Up to 3 years - from baseline to RECIST confirmed Progressive Disease

• Dose Escalation phase: Duration of response (DOR)

  Up to 3 years

• Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)

  Up to 3 years

• Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)

  Up to 3 years

Study Arms (2)

Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation

EXPERIMENTAL

Dose escalation of JAB-BX102 will be administered as monotherapy to determine the MTD and RP2D.

Biological: JAB-BX102 (anti-CD73 monoclonal antibody)

Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion

EXPERIMENTAL

JAB-BX102 will be administered in combination with pembrolizumab in specific solid tumor patients to evaluate the preliminary antitumor activity.

Biological: JAB-BX102 (anti-CD73 monoclonal antibody); Biological: pembrolizumab (anti-PD-1 monoclonal antibody)

Interventions

JAB-BX102 (anti-CD73 monoclonal antibody) BIOLOGICAL

Administered by intravenous infusion (IV)

Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation; Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion

pembrolizumab (anti-PD-1 monoclonal antibody) BIOLOGICAL

Administered by intravenous infusion (IV)

Also known as: KEYTRUDA®

Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to provide an archived tumor sample
• Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor
• Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition, or patient has no access to SOC treatment.
• Must have at least 1 measurable lesion per RECIST v1.1
• Must have adequate organ functions

You may not qualify if:

• Has central nervous system(CNS) metastases or carcinomatous meningitis, except if CNS metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days
• Active infection requiring systemic treatment within 7 days
• Active hepatitis C virus(HBV), hepatitis C virus(HCV), or HIV
• Any severe and/or uncontrolled medical conditions
• Left ventricular ejection fraction(LVEF) ≤50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA)
• QTcF(Corrected QT interval - Fredericia formula) interval \>470 msec
• Experiencing unresolved CTCAE 5.0 Grade \>1 toxicities

Sponsors & Collaborators

• Jacobio Pharmaceuticals Co., Ltd.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (6)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 3, 2022
• Study Start: August 18, 2022
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

CN (6)