A Phase 1/2 interventional study of AZD6750 and rilvegostomig in Melanoma, Non-small Cell Lung Cancer and Squamous Cell Carcinoma (Skin), sponsored by AstraZeneca. Recruiting at 13 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants with Select Advanced or Metastatic Solid Tumors
3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's planned enrollment of 120 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 358 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Module 1 specific inclusion criteria:
Module 2 specific inclusion criteria:
Participants with Stage IV NSCLC Dose Escalation/Backfills
Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
Dose Expansion
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Exclusion criteria:
Severe or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions
Module 2 specific exclusion criteria:
AZD6750 administered intravenously (IV) as a single agent
Drug: AZD6750
AZD6750 given in combination with rilvegostomig (IV)
Drug: AZD6750 · Drug: rilvegostomig
AZD6750- CD8 guided IL-2
Rilvegostomig- PD1-TIGIT bispecific antibody
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.
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)
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)
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).
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)
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
PK Area Under Curve (AUC)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
To assess the Area Under Curve (AUC) 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
PK Time to maximum plasma concentration (tmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
To assess the time to maximum 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
PK Clearance- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
To assess the clearance 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
PK Half-life- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
To assess the PK half-time 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 depending on Module/dosing schedule.
Time frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
PK Minimum observed concentration (Cmin)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
To assess the minimum observed concentration (Cmin) 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
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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