A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT05123482
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD8205 — DRUG
    AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial cancers and squamous non-small cell lung cancers.
  • AZD8205 and AZD2936 (Rilvegostomig) — DRUG
    AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial cancers and squamous non-small cell lung cancers. Rilvegostomig is a bispecific antibody that specifically binds to human TIGIT and PD-1 and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
  • AZD8205 and AZD5305 (saruparib) — DRUG
    AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial and squamous non-small cell lung cancers. Saruparib is a PARP inhibitor that stops the PARP protein from doing its repair work in damaged cancer cells, resulting in cell death, and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
  • AZD8205 and AZD5305 (saruparib) and AZD2936 (rilvegostomig) — DRUG
    AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial and squamous non-small cell lung cancers. Saruparib is a PARP inhibitor that stops the PARP protein from doing its repair work in damaged cancer cells, resulting in cell death, and is a potential anticancer therapy in patients with advanced or metastatic solid tumors. Rilvegostomig is a bispecific antibody that specifically binds to human TIGIT and PD-1 and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
  • AZD8205 in combination with AZD9574 — DRUG
    AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial and squamous non-small cell lung cancers. AZD9574 is a PARP inhibitor that stops the PARP protein from doing its repair work in damaged cancer cells, resulting in cell death, and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.
  • AZD8205 in combination with AZD9574 plus rilvegostomig (AZD2936) — DRUG
    AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, endometrial and squamous non-small cell lung cancers. AZD9574 is a PARP inhibitor that stops the PARP protein from doing its repair work in damaged cancer cells, resulting in cell death, and is a potential anticancer therapy in patients with advanced or metastatic solid tumors. Rilvegostomig is a bispecific antibody that specifically binds to human TIGIT and PD-1 and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.

Study Details

This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone or in combination with anti-cancer agents

Key Dates

Start date
Oct 18, 2021
Status verified
May 2026
Primary completion
Sep 29, 2027
Completion
Sep 29, 2027

Study Design

Enrollment
460 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Sub-Study 1 AZD8205 Monotherapy
    Sub-Study 1 has two parts: Part A : The aim is to determine the safety, tolerability, Recommended Phase 2 Dose (RP2D), and/or the Maximum Tolerated Dose (MTD) of AZD8205. Part B: The aim of dose expansion is to evaluate anti-tumor activity of AZD8205 as monotherapy in select solid tumors.
  • Experimental: Sub Study 2: AZD8205 in combination with rilvegostomig
    Sub-Study 2 has two parts: Part A : Dose escalation to determine the safety, tolerability of AZD8205 + rilvegostomig Part B: Dose expansion to evaluate anti-tumor activity of AZD8205 + rilvegostomig in select solid tumors.
  • Experimental: Sub-Study 3 AZD8205 in combination with saruparib, with or without rilvegostomig
    Sub-Study 3 has two parts: Part A : Dose escalation to determine the safety, tolerability of AZD8205 + saruparib. Rilvegostomig may be added in a triplet combination once an AZD8205 + saruparib combination dose/schedule has been considered safe. Part B: Dose expansion to evaluate anti-tumor activity of AZD8205 + saruparib with or without rilvegostomig in select solid tumors.
  • Experimental: Sub-Study 4: AZD8205 in combination with AZD9574 with or without rilvegostomig (AZD2936)
    Sub-Study 4 has two parts: Part A : Dose escalation to determine the safety, tolerability of AZD8205 + AZD9574. Rilvegostomig may be added in a triplet combination once an AZD8205 + AZD9574 combination dose/schedule has been considered safe. Part B: may be added in the future depending on emerging data, following a formal protocol amendment.

Primary Outcome Measure

The number of patients with adverse events [ Time Frame: From time of Informed consent to 30 days post last dose (approximately 1 year). ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteIrvineCalifornia92618-
Research SiteSanta MonicaCalifornia90404-
Research SiteSanta RosaCalifornia95403-
Research SiteShreveportLouisiana71103-
Research SiteBaltimoreMaryland21231-
Research SiteBostonMassachusetts02215-
Research SiteSt LouisMissouri63110-
Research SiteAlbuquerqueNew Mexico87109-
Research SiteCommackNew York11725-
Research SiteNew YorkNew York10029-
Research SiteCharlotteNorth Carolina28204-
Research SitePittsburghPennsylvania15213-
Research SiteHoustonTexas77030-

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