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NCT Number: NCT05174585

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

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.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

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About this study

The primary objective of this study is to evaluate the safety and tolerability of JAB-BX102 monotherapy to determine the MTD(maximum tolerated dose) and RP2D(Recommended Phase 2 Dose) during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-BX102 is administered in combination with pembrolizumab during Dose Expansion phase in patients with advanced solid tumors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

JAB-BX102 (anti-CD73 monoclonal antibody)

Biological

Administered by intravenous infusion (IV)

pembrolizumab (anti-PD-1 monoclonal antibody)

Biological

Administered by intravenous infusion (IV)

Other names: KEYTRUDA®

Primary outcomes

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

    Time frame: First 21 days of Cycle 1

    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.

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

    Time frame: Up to 3 years

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

  3. Dose Expansion phase: Overall response rate (ORR)

    Time frame: Up to 3 years - from baseline to RECIST confirmed Progressive Disease

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

  4. Expansion phase: Duration of response (DOR)

    Time frame: Up to 3 years

    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.

Secondary outcomes

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

    Time frame: Up to 3 years

    observed plasma concentration of JAB-BX102

  2. Dose Escalation phase: Overall response rate (ORR)

    Time frame: Up to 3 years - from baseline to RECIST confirmed Progressive Disease

    The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.

  3. Dose Escalation phase: Duration of response (DOR)

    Time frame: Up to 3 years

    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.

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

    Time frame: Up to 3 years

    DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per CTCAE v1.1.

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

    Time frame: Up to 3 years

    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first

Sponsors and collaborators

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd.

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2022
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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