Health Trials

Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors

ConditionsOvarian CancerLung AdenocarcinomaEndometrial CancerLung Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced tumors

Eligibility criteria

Qualifiers

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative. Participants who do not provide informed consent for Optional Genetic Research may still be enrolled in the study.

Participant must be ≥ 18 years at the time of signing the informed consent.

Willing to provide adequate archival and/or baseline tumor sample as applicable per module-specific criteria.

Disqualifiers

Patients with spinal cord compression or a history of leptomeningeal carcinomatosis.

Patients with brain metastases unless, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent for at least 4 weeks prior to first dose of study intervention.

Treatment with any of the protocol defined medications, without adequate washout periods or time before the first dose of study intervention.

Unresolved toxicities of Grade ≥ 2 (National Cancer Institute [NCI] CTCAE v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy). Participants with stable ≤ Grade 2 neuropathy are eligible.

Trial design

Treatments tested in this trial

  • Torvutatug samrotecan
  • Saruparib
  • Bevacizumab
  • Carboplatin
  • Palacaparib
  • Pembrolizumab

Treatment groups

506 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov