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A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies

ConditionsChronic Lymphocytic LeukaemiaSmall Lymphocytic LymphomaMantle-cell LymphomaLarge B-cell LymphomaB-cell Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Contraception use during treatment and at least 90 days after final dose.

Confirmed CD19 expression if prior anti-CD19 therapy.

Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.

Disqualifiers

Central nervous system (CNS) lymphoma.

Surgery within 14 days of study drug.

Clinically significant cardiovascular (CV) disease.

Unresolved Grade >2 AEs from prior anticancer therapy (except alopecia or fatigue).

Trial design

Design model

Sequential

Treatments tested in this trial

  • Surovatamig

    Drug

    Surovatamig will be administered as either SC injection or IV infusion.

  • Prednisone (or equivalent)

    Drug

    Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.

  • Rituximab

    Drug

    Rituximab will be administered as IV infusion as per standard of care.

  • Cyclophosphamide

    Drug

    Cyclophosphamide will be administered as IV infusion as per standard of care.

  • Vincristine

    Drug

    Vincristine will be administered as IV infusion as per standard of care.

  • Doxorubicin

    Drug

    Doxorubicin will be administered as IV infusion as per standard of care.

  • Acalabrutinib

    Drug

    Acalabrutinib will be administered orally

Treatment groups

408 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Substudy 1 (RR CLL/SLL): Cohort 1A (Surovatamig Monotherapy)Experimental treatment 1 intervention
Group B: Substudy 1 (RR CLL/SLL): Cohort 1B (Surovatamig + Acalabrutinib)Experimental treatment 2 interventions
Group C: Substudy 1 (RR CLL/SLL): Cohort 1C (Surovatamig Monotherapy)Experimental treatment 1 intervention
Group D: Substudy 2 (RR MCL): Cohort 2A (Surovatamig Monotherapy)Experimental treatment 1 intervention
Group E: Substudy 2 (RR MCL): Cohort 2C (Surovatamig Monotherapy)Experimental treatment 1 intervention
Group F: Substudy 3 (LBCL): Cohort 3A 2SUD (Surovatamig + RCHOP)Experimental treatment 6 interventions
Group G: Substudy 3 (LBCL): Cohort 3B 3SUD (Surovatamig + RCHOP)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest

Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.

Time frame
Up to 6 years 4 months
2

Number of Participants with Dose Limiting Toxicity (DLTs)

Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.

Time frame
Up to 2 months

Secondary outcomes

1

Overall Response Rate (ORR)

ORR is defined as percentage of participants achieving either a partial response (PR) or complete response (CR) based on response criteria for International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving either PR or CR based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3).

Time frame
Up to 6 years 4 months
2

Complete Response (CR) Rate

CR rate is defined as percentage of participants achieving CR as best response based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving CR as best response based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3).

Time frame
Up to 6 years 4 months
3

Duration of Response (DoR)

DoR is defined as time from the date of first documented response until date of documented progression based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator, relapse or death (substudy 1) and time from the date of first documented response until date of documented progression based on Lugano 2014 Response Criteria by investigator assessment, relapse or death (substudies 2 and 3).

Time frame
Up to 6 years 4 months
4

Maximum Observed Concentration (Cmax)

The PK (Cmax) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.

Time frame
Up to 90 days after last dose

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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