Health TrialsbyHealthPanel

A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)

ConditionsSolid TumorsNeoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline

About this trial

The goal of this study is to assess the safety and tolerability of Mocertatug Rezetecan . The study will also see how the levels of Mo-Rez change over time at different dose amount

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females aged 18 years or older (≥18 years).

Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care.

PROC cohort

Histologically documented, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer.

Disqualifiers

Have received any B7-H4-targeted therapy

Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.

Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.

Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion

Trial design

Design model

Sequential

Treatments tested in this trial

  • Mocertatug rezetecan

    Drug

    Mocertatug rezetecan will be administered

Treatment groups

675 Participants
are divided into 2 treatment groups
Group A: Part 1: Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Number of participants with dose limiting toxicity (DLT)

Time frame
Up to 21 days
2

Part 2-Confirmed Objective Response Rate (ORR) assessed by investigator

ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Time frame
Up to approximately 28 months

Secondary outcomes

1

Part 1 and 2: Maximum observed concentration (Cmax) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin

Time frame
Up to approximately 31 months
2

Part 1 and 2: Time to reach Cmax (Tmax) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin

Time frame
Up to approximately 31 months
3

Part 1 and 2: Area under the concentration-time curve (AUC) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin

Time frame
Up to approximately 31 months
4

Part 1- Confirmed Objective Response Rate assessed by investigator

ORR is defined as the proportion of participants with at least one confirmed CR or PR as defined by RECIST 1.1

Time frame
Up to approximately 31 months

Other outcomes

Sponsors and contacts

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

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
Apply now