NCT03729596 : A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy,Treatment | Breast,Lung,Urinary systemBreast,Lung,Non-Small Cell Lung Cancer,Prostate

Trial Overview Read MoreRead more

This phase I/II trial will begin to understand how safe and tolerable a new type of targeted therapy is for patients with advanced solid cancers, given as a monotherapy (alone) or in combination with another targeted cancer therapy.
 

This trial is treating patients with advanced solid cancers, including metastatic castrate resistant prostate cancer, non-small cell lung cancer or triple negative breast cacer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors

Commercial Sponsor

MacroGenics

Summary

This study will characterise safety, dose-limiting toxicities (DLTs), maximum tolerated/administered dose (MTD/MAD) and anti-tumour activity for MGC018 as monotherapy (Module A) or in combination with MGA012 (Module B). Each module consists of a Dose Escalation Phase, followed by a Cohort Expansion Phase. Patients with solid tumours will be enrolled in the Dose Escalation Phase; Cohort Expansion will include patients with metastatic castrate-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and triple-negative breast cancer (TNBC). Patients who do not experience unacceptable toxicity or meet criteria for permanent discontinuation may undergo additional cycles for up to two years. Patients in Cohort Expansion will be followed for survival every 3 months for 2 years following last dose.

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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