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

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

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

Treatments tested in this trial

  • Mocertatug rezetecan

Treatment groups

675 Participants
are divided into 2 treatment groups

Locations

65
Argentina
GSK Investigational SiteR8324CVE, Cipoletti Rio Negro Argentina
GSK Investigational Site1118, Ciudad de Buenos Aires Argentina
GSK Investigational SiteB1900AVG, La Plata Argentina
GSK Investigational SiteS2002, Rosario Argentina

Sponsors and collaborators

GlaxoSmithKline

Lead sponsor