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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Relapsed/metastatic solid tumors treated with prior adequate standard of care therapy for tumor type and stage of disease or where in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and/or tolerability to prior therapy.

Measurable disease per RECIST v1.1

Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1

Disqualifiers

Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment

Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 28 days (whichever is shorter) prior to the first dose of study treatment

Cytotoxic treatment: 21 days

Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

460 Participants
are divided into 4 treatment groups
Group A: Sub-Study 1 AZD8205 MonotherapyExperimental treatment 1 intervention
Group B: Sub Study 2: AZD8205 in combination with rilvegostomigExperimental treatment 1 intervention
Group C: Sub-Study 3 AZD8205 in combination with saruparib, with or without rilvegostomigExperimental treatment 2 interventions
Group D: Sub-Study 4: AZD8205 in combination with AZD9574 with or without rilvegostomig (AZD2936)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The number of patients with adverse events

Number of patients with adverse events by system organ class and preferred term

Time frame
From time of Informed consent to 30 days post last dose (approximately 1 year).
2

The number of patients with serious adverse events

Number of patients with serious adverse events by system organ class and preferred term

Time frame
From time of Informed consent to 30 days post last dose (approximately 1 year)
3

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

A DLT is defined as any toxicity that occurs from the first dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation and which includes pre-defined haematological and non-haematological toxicities.

Time frame
From first dose of study treatment until the end of Cycle 1 (approximately 21 days).
4

The number of patients with changes from baseline laboratory findings, ECGs and vital signs

Description of laboratory findings and vital signs variables over time including change from baseline.

Time frame
From time of informed consent to 30 days post last dose (approximately 1 year)

Secondary outcomes

1

Objective Response Rate (ORR)

The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1).

Time frame
From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years )
2

Duration of response (DoR)

The time from the date of first response until date of disease progression (RECIST 1.1) or death in the absence of disease progression.

Time frame
From the first documented response to confirmed progressive disease or death ( approx. 2 years )
3

Progression free Survival (PFS)

The time from first dose until RECIST 1.1 defined disease progression or cessation of study treatment.

Time frame
From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years )
4

Disease Control Rate at 12 weeks (DCR-12)

Percentage of patients with confirmed CR or PR or having SD maintained for \>= 11 weeks from first dose (RECIST 1.1).

Time frame
Measured from first dose until progression. For each patient, this is expected to be at 12 weeks

Other outcomes

Sponsors and contacts

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