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Soundtrack-ENCT06564038

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

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

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Record History

All 18 versions: 15 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jun 11, 2029 to May 20, 2030 Show 4 more changesShow less
    • Study sites: 65 to 66
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 1 of 11 entries
    • Study description expanded, about 3 words
  2. Study sites: 64 to 65v17
  3. Primary completion pushed from Feb 28, 2028 to Jun 11, 2029v15
  4. Site details revised at 1 of 64 sitesv14
  5. Site details revised at 3 of 64 sitesv12
  6. Enrollment increased: 276 → 408 participantsv11 Show 7 more changesShow less
    • Study completion pushed from Feb 28, 2028 to Jun 11, 2029
    • Trial arms changed: 6 → 7
    • Study sites: 63 to 64
    • Interventions: AZD0486 (Drug), Acalabrutinib (Drug), Cyclophosphamide (Drug), Doxorubicin (Drug), Prednisone (or equivalent) (Drug), Rituximab (Drug)… to Acalabrutinib (Drug), Cyclophosphamide (Drug), Doxorubicin (Drug), Prednisone (or equivalent) (Drug), Rituximab (Drug), Surovatamig (Drug)…
    • Eligibility criteria expanded, about 72 words
    • Secondary endpoints revised (11)
    • Study description revised
  7. Site details revised at 1 of 63 sitesv10
  8. Site details revised at 1 of 63 sitesv8
  9. Study sites: 59 to 63v7
  10. Primary and study completion dates: Apr 25, 2031 to Feb 28, 2028
    • Study sites: 57 to 59
    v6
  11. Study sites: 56 to 57v5
  12. Enrollment target: 180 to 276v4 Show 5 more changesShow less
    • Study sites: 54 to 56
    • Interventions: AZD0486 (Drug), Acalabrutinib (Drug), Cyclophosphamide (Drug), Doxorubicin (Drug), Prednisone (Drug), Rituximab (Drug), Vincristine (Drug) to AZD0486 (Drug), Acalabrutinib (Drug), Cyclophosphamide (Drug), Doxorubicin (Drug), Prednisone (or equivalent) (Drug), Rituximab (Drug)…
    • Eligibility criteria shortened, about 15 words
    • Study description revised
    • Study arms: 5 to 6
  13. Study sites: 50 to 54v3
  14. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 13, 2024 to Jan 30, 2025
    • Study sites: 0 to 50
    • Primary and study completion dates: Jan 31, 2031 to Apr 25, 2031
    v2
  15. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Timeframe: Up to 6 years 4 months
Number of Participants with Dose Limiting Toxicity (DLTs)
Timeframe: Up to 2 months

Secondary (11)

Overall Response Rate (ORR)
Complete Response (CR) Rate
Duration of Response (DoR)
Maximum Observed Concentration (Cmax)
Area Under the Concentration-time Curve (AUC)
Show 6 moreShow less
Minimum Observed Concentration (Cmin)
Time to Reach Maximum Concentration (tmax)
Trough Plasma Concentration (Ctrough)
Half Life (t1/2) of surovatamig
Clearance (CL) of surovatamig
Number of Participants with Anti-drug Antibody (ADA) for surovatamig

Arms and interventions

Substudy 1 (RR CLL/SLL): Cohort 1A (Surovatamig Monotherapy)Experimental

Participants will receive surovatamig monotherapy as subcutaneous (SC) injection.

Substudy 1 (RR CLL/SLL): Cohort 1B (Surovatamig + Acalabrutinib)Experimental

Participants will receive surovatamig as SC injection. Participants will receive acalabrutinib tablet orally twice daily.

Substudy 1 (RR CLL/SLL): Cohort 1C (Surovatamig Monotherapy)Experimental

Participants will receive surovatamig monotherapy as intravenous (IV) infusion.

Substudy 2 (RR MCL): Cohort 2A (Surovatamig Monotherapy)Experimental

Participants will receive surovatamig monotherapy as SC injection.

Substudy 2 (RR MCL): Cohort 2C (Surovatamig Monotherapy)Experimental

Participants will receive surovatamig monotherapy as IV infusion.

Substudy 3 (LBCL): Cohort 3A 2SUD (Surovatamig + RCHOP)Experimental

Participants will receive surovatamig as IV infusion with a 2SUD (double step-up dosing) schedule for priming in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.

Substudy 3 (LBCL): Cohort 3B 3SUD (Surovatamig + RCHOP)Experimental

Participants will receive surovatamig as IV infusion with a 3SUD (triple step-up dosing) schedule for priming in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.

Drugs: Surovatamig, Prednisone (or equivalent), Rituximab, Cyclophosphamide, Vincristine, Doxorubicin, Acalabrutinib

Sites

66 sites in 13 countries

United States 14, Germany 6, South Korea 6, Spain 6, China 5, France 5, Denmark 4, Taiwan 4, United Kingdom 4, Australia 3, Czechia 3, Italy 3, Japan 3