Study identifier:D8242C00001
ClinicalTrials.gov identifier:NCT05205161
EudraCT identifier:2021-003410-39
CTIS identifier:N/A
A Modular Phase I/II, Open-label, Dose Escalation and Expansion, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0466 as Monotherapy or in Combination with Anticancer Agents in Patients with Advanced Non-Hodgkin Lymphoma.
Non-Hodgkin Lymphoma
Phase 1
No
AZD0466
All
7
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Part A (Dose Escalation): Dose Level (DL)-1 Participants with advanced R/R B-NHL will receive AZD0466 on day 1 , day 4, day 8 day 15, day 22 of cycle 1 and day 1, day 8 day 15, day 22 of cycle 2 and beyond until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first. | Drug: AZD0466 All patients will receive treatment with the investigational product AZD0466 via intravenous infusion. |
Experimental: Part A (Dose Escalation): DL1 Participants with advanced R/R B-NHL will receive AZD0466 on day 1 , day 4, day 8 day 15, day 22 of cycle 1 and day 1, day 8 day 15, day 22 of cycle 2 and beyond until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first. | Drug: AZD0466 All patients will receive treatment with the investigational product AZD0466 via intravenous infusion. |
Experimental: Part A (Dose Escalation): DL2 Participants with advanced R/R B-NHL will receive AZD0466 on day 1 , day 4, day 8 day 15, day 22 of cycle 1 and day 1, day 8 day 15, day 22 of cycle 2 and beyond until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first. | Drug: AZD0466 All patients will receive treatment with the investigational product AZD0466 via intravenous infusion. |
Experimental: Part A (Dose Escalation): DL3 Participants with advanced R/R B-NHL will receive AZD0466 on day 1 , day 4, day 8 day 15, day 22 of cycle 1 and day 1, day 8 day 15, day 22 of cycle 2 and beyond until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first. | Drug: AZD0466 All patients will receive treatment with the investigational product AZD0466 via intravenous infusion. |
Experimental: Part A (Dose Escalation): DL4 Participants with advanced R/R B-NHL will receive AZD0466 on day 1 , day 4, day 8 day 15, day 22 of cycle 1 and day 1, day 8 day 15, day 22 of cycle 2 and beyond until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first. | Drug: AZD0466 All patients will receive treatment with the investigational product AZD0466 via intravenous infusion. |
Experimental: Part B (Dose Expansion): Cohort B1 (R/R MCL) Participants with advanced R/R MCL will receive AZD0466 at the recommended phase 2 dose (RP2D) until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first. | Drug: AZD0466 All patients will receive treatment with the investigational product AZD0466 via intravenous infusion. |
Experimental: Part B (Dose Expansion): Cohort B2 (R/R FL or MZL) Participants with advanced R/R FL or MZL will receive AZD0466 at the recommended phase 2 dose (RP2D) until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first. | Drug: AZD0466 All patients will receive treatment with the investigational product AZD0466 via intravenous infusion. |
Experimental: Part B (Dose Expansion): Cohort B3 (R/R DLBCL) Participants with advanced R/R DLBCL will receive AZD0466 at the recommended phase 2 dose (RP2D) until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first. | Drug: AZD0466 All patients will receive treatment with the investigational product AZD0466 via intravenous infusion. |