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Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

ConditionsSolid TumorAdvanced CancerMetastatic CancerGastric CancerGastroesophageal Junction CarcinomaEsophageal AdenocarcinomaPDAC - Pancreatic Ductal AdenocarcinomaBiliary Tract Cancer (BTC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorI-Mab Biopharma US Limited

About this trial

This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function

Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)

Disqualifiers

Prior exposure to CLDN18.2 -targeted therapy

Prior exposure to 4-1BB agonists

Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ

Known active or chronic Hepatitis B or Hepatitis C, other hepatitides

Trial design

Design model

Sequential

Treatments tested in this trial

  • TJ033721 (givastomig)

    Drug

    Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)

  • TJ033721 (givastomig) , nivolumab, chemotherapy

    Drug

    Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy

  • TJ033721 (givastomig), chemotherapy

    Drug

    Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), chemotherapy

  • TJ033721 (givastomig), durvalumab, chemotherapy

    Drug

    Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), durvalumab, chemotherapy

Treatment groups

330 Participants
are divided into 4 treatment groups
Group A: TJ033721 (givastomig)Experimental treatment 1 intervention
Group B: TJ033721 (givastomig) in combination with nivolumab and chemotherapyExperimental treatment 1 intervention
Group C: TJ033721 (givastomig) in combination chemotherapyExperimental treatment 1 intervention
Group D: TJ033721 (givastomig) in combination with durvalumab and chemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicities (DLTs)

Time frame
28 days
2

Incidence and severity of AEs

The CTCAE criteria will be used to assess adverse events on this trial.

Time frame
Up to 100 days post last dose
3

Maximum tolerated or administered dose (MTD, MAD)

Based on DLT definitions

Time frame
28 Days

Secondary outcomes

1

Pharmacokinetic (PK) Parameters: AUC∞

Area under the curve from time zero extrapolated to infinity (AUC∞)

Time frame
Up to 100 days post last dose
2

Pharmacokinetic (PK) Parameters: AUCt

AUC from time zero to the time of the last quantifiable concentration (AUC0-t)

Time frame
up to 100 days post last dose
3

Pharmacokinetic (PK) Parameters: Cmax

Maximum observed concentration

Time frame
up to 100 days post last dose
4

Pharmacokinetic Parameters: Tmax

Time of peak concentration (Tmax)

Time frame
up to 100 days post last dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

I-Mab Biopharma US Limited

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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