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A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

ConditionsMelanomaNon-small Cell Lung CancerSquamous Cell Carcinoma (Skin)Renal Cell CarcinomaMerkel Cell CarcinomaTriple Negative Breast CancerHead and Neck Squamous Cell CarcinomaGastric Cancer/Gastroesophageal Junction CancerHigh Grade Serous Ovarian Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant ≥ 18 year

ECOG PS of 0 to 1

Provision of 'archival' tumor specimen

At least one measurable lesion according to RECIST v1.1,

Disqualifiers

History or planned organ or allogeneic stem cell transplantation.

Active or prior documented autoimmune or inflammatory disorders, within the past 3 years

Any prior toxicities that led to permanent discontinuation of prior immunotherapy

Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZD6750

    Drug

    AZD6750- CD8 guided IL-2

  • rilvegostomig

    Drug

    Rilvegostomig- PD1-TIGIT bispecific antibody

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Module 1Experimental treatment 1 intervention
Group B: Module 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety- Part 1A & Part 2A (dose escalation) and Part 2B (dose expansion)

To assess the safety and tolerability, characterize the DLTs, and determine the MTD and RP2D(s) of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module

Time frame
Measured from the informed consent until Day 90 post-last dose.
2

Efficacy- Part 2B only (dose expansion)

To assess the preliminary anti-tumor activity of AZD6750 in combination with other anti-cancer agents.

Time frame
Measured every 6 weeks for 48 weeks and every 12 weeks thereafter from first dose until disease progression or death in the absence of disease progression(approximately 2 years)

Secondary outcomes

1

Pharmacodynamic- Part 1A & Part 2A (dose escalation) and Part B (dose expansion)

To assess immunomodulatory biomarker PD-L1 at baseline and on treatment as a single agent and in combination with other anti-cancer agents as specified in each respective module

Time frame
Measured with baseline and On-treatment biopsy. On-treatment biopsy is planned during Cycle 2 during Cycle 2 (each cycle is 28 days or 21 days depending on Module/dosing schedule)
2

Immunogenicity- Part 1A & 2A (dose escalation) and Part 2B (dose expansion)

To assess the incidence of anti-drug antibodies (ADA) against AZD6750 in serum and in combination with other anti-cancer agents as specified in each respective module

Time frame
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose. Each cycle is 28 days or 21 days depending on Module/dosing schedule).
3

Efficacy (Part 1A and 2A)

To assess the preliminary anti-tumor activity of AZD6750 alone and in combination with other anti-cancer agents.

Time frame
Measured every 6 weeks for 48 weeks and every 12 weeks thereafter thereafter from first dose until disease progression or death in the absence of disease progression (approximately 2 years)
4

PK Maximum plasma concentration (Cmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)

To assess the plasma concentration of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule)

Time frame
Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals

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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