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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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Torvutatug samrotecan

    Drug

    IV Antibody-drug conjugate

  • Saruparib

    Drug

    Oral PARP inhibitor

  • Bevacizumab

    Drug

    IV Monoclonal antibody

  • Carboplatin

    Drug

    IV Alkylating agent

  • Palacaparib

    Drug

    Oral PARP inhibitor

  • Pembrolizumab

    Drug

    IV Biologic

Treatment groups

622 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Module 1: Torvu-sam MonotherapyExperimental treatment 1 intervention
Group B: Module 2: Torvu-sam + SaruparibExperimental treatment 2 interventions
Group C: Module 3: Torvu-sam + BevacizumabExperimental treatment 2 interventions
Group D: Module 4: Torvu-sam + Carboplatin +/- BevacizumabExperimental treatment 3 interventions
Group E: Module 5: Torvu-sam + Palacaparib +/- BevacizumabExperimental treatment 3 interventions
Group F: Module 6: Torvu-sam + Pembrolizumab +/- PalacaparibExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of participants with adverse events/serious adverse events

Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination.

Time frame
From time of Informed Consent to 30 days post last dose.
2

The number of participants with dose limiting toxicity(DLT), as defined in the protocol

A DLT is defined as any ≥ Grade 3 treatment-emergent AE that occurs during the DLT evaluation period, not attributable to the underlying disease or extraneous causes (as defined in the protocol)

Time frame
From the first dose of torvu-sam on Cycle 1 Day 1 up to and including the planned end of Cycle 1 (At the end of 21 days)

Secondary outcomes

1

Objective Response Rate (ORR)

The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria.

Time frame
From time of Informed Consent to progressive disease or withdrawal of consent.(approx 2 years)
2

Duration of Response (DoR)

The time from the date of first response until date of disease progression or death in the absence of disease progression.

Time frame
From the first documented response to confirmed progression or death in the absence of disease progression.(approx 2 years)
3

Disease Control Rate (DCR)

The percentage of participants who have a best objective response of confirmed CR or PR or who have SD for at least 15 weeks after start of treatment (to allow for an early assessment within the assessment window).

Time frame
From time of Informed Consent until progression.(approx 15 weeks)
4

Progression free Survival (PFS)

Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from assigned therapy or receives another anti-cancer therapy prior to progression. Participants who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment

Time frame
From time of first dose of torvu-sam or anti-cancer study agent until the date of objective disease progression or death (by any cause in the absence of progression) (approx 2 years)

Other outcomes

Sponsors and contacts

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

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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