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JOURNAL ONKOLOGIE – STUDIE

Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Rekrutierend

NCT-Nummer:
NCT05216835

Studienbeginn:
März 2022

Letztes Update:
15.03.2024

Wirkstoff:
AZD7789

Indikation (Clinical Trials):
Lymphoma, Hodgkin Disease

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
AstraZeneca

Collaborator:
Parexel

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen

Studienlocations
(3 von 24)

Research Site
50924 Köln
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a Phase I/II, open-label multi-center study will have AZD7789 administered via

intravenous infusion on Cycle 1 Day 1 to adult/young adult patients with relapsed/refractory

classical Hodgkin Lymphoma (r/r cHL). This study will have 2 parts: Phase 1 (Part A) Dose

Escalation and Phase 2 (Part B) Dose Expansion.

Patients will be treated with study intervention for a maximum of 35 cycles, or until disease

progression, unacceptable toxicity, withdrawal of consent, or if other reasons to discontinue

treatment occur.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- ≥ 16 years of age at the time of obtaining informed consent

- Eastern Cooperative Oncology Group performance status of 0 or 1 at screening

- At least one PET-avid measurable lesion according to Modified Lugano Criteria after

the last line of therapy.

- Confirmed histological diagnosis of active relapse/refractory cHL

- Failed at least 2 prior lines of systemic therapy.

- No previous treatment with anti-TIM-3.

- Adequate organ and bone marrow function

- Non-pregnant women and willingness of female patients to avoid pregnancy or male

participants willing to avoid fathering children through highly effective methods of

contraception

- Minimum body weight ≥ 40 kg for all participants.

Exclusion Criteria:

- Unresolved toxicities of ≥ Grade 2 from prior therapy

- Any prior ≥ Grade 3 imAE while receiving prior checkpoint inhibitor immunotherapy

- Patients with CNS involvement or leptomeningeal disease.

- History of organ transplantation (e.g., stem cell or solid organ transplant).

- Any venous or arterial thromboembolic event within ≤ 6 months prior to the first dose

of study intervention.

- Active infection including TB, HIV, hepatitis A, chronic or active hepatitis B,

chronic or active hepatitis C, active COVID-19 infection

- History of arrhythmia which is requires treatment, symptomatic or uncontrolled atrial

fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia

- Uncontrolled intercurrent illness.

- Active or prior documented pathologically confirmed autoimmune or inflammatory

disorders.

- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation

pneumonitis requiring steroid treatment, or any evidence of clinically active ILD

- Other invasive malignancy within 2 years prior to screening

- Congenital long QT syndrome or history of QT prolongation associated with other

medications that cannot be changed or discontinued based on a cardiologist assessment

- Current or prior use of immunosuppressive medication within 14 days prior to the first

dose of study intervention

- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal

therapy for cancer treatment.

Studien-Rationale

Primary outcome:

1. Part A (Dose Escalation): Number of incidence of adverse events (AEs) (Time Frame - Approximately up to 2 years 90 days):
To assess safety and tolerability of AZD7789 in patients with r/r cHL.

2. Part A (Dose Escalation): Number of patients with dose-limiting toxicities (DLTs) (Time Frame - From first dose until 28 days from the last patient first dose [within 28 days DLT period]):
To determine the maximum tolerated dose (MTD). To determine the incidence of DLT.

3. Part B (Dose Expansion): Cohort B1: Objective response rate (ORR) (Time Frame - Up to 2 years of treatment):
To assess anti-tumor activity of AZD7789 in patients with r/r cHL. ORR defined as CR + PR as per modified Lugano criteria (Lugano 2014).

4. Part B (Dose Expansion): Cohort B2: Complete response rate (CRR) (Time Frame - Up to 2 years of treatment):
To assess anti-tumor activity of AZD7789 in patients with r/r cHL. CRR is defined as CR as per modified Lugano criteria (Lugano 2014).

5. Part B (Dose Expansion): Number of incidence of adverse events (AEs) (Time Frame - Approximately up to 2 years 90 days):
To assess safety and tolerability of AZD7789 in patients with r/r cHL.

Secondary outcome:

1. Part A (Dose Escalation): Complete Response Rate (CRR) (Time Frame - Up to 2 years of treatment):
To assess anti-tumor activity of AZD7789 in patients with r/r cHL. CRR is defined as CR as per modified Lugano criteria (Lugano 2014).

2. Part A (Dose Escalation): Objective Response Rate (ORR) (Time Frame - Up to 2 years of treatment):
To assess anti-tumor activity of AZD7789 in patients with r/r cHL. ORR defined as CR + PR as per modified Lugano criteria (Lugano 2014).

3. Part A (Dose Escalation): Duration of Response (DoR) (Time Frame - Up to approximately 5 years):
To assess DoR of AZD7789 in patients with r/r cHL.

4. Part A (Dose Escalation): Duration of Complete Response (DoCR) (Time Frame - Up to approximately 5 years):
To assess DoCR of AZD7789 in patients with r/r cHL

5. Part A (Dose Escalation): Progression-free Survival (PFS) (Time Frame - Up to approximately 5 years):
To assess anti-tumor activity of AZD7789 in patients with r/r cHL.

6. Part A (Dose Escalation): Overall Survival (OS) (Time Frame - Up to approximately 5 years):
To assess anti-tumor activity of AZD7789 in patients with r/r cHL.

7. Part A (Dose Escalation): Number of patients with positive anti-drug antibodies against AZD7789 in serum (Time Frame - Up to 2 years):
To assess the presence of anti-drug antibodies for AZD7789 in treated patients with r/r cHL.

8. Part A (Dose Escalation): Maximum observed concentration (Cmax) (Time Frame - Up to 2 years):
To assess the Cmax of AZD7789 in patients with r/r cHL.

9. Part A (Dose Escalation): Area under the concentration-time curve (AUC) (Time Frame - Up to 2 years):
To assess AUC of AZD7789 in patients with r/r cHL.

10. Part A (Dose Escalation): Terminal elimination half-life (t½) (Time Frame - Up to 2 years):
To assess t½ of AZD7789 in patients with r/r cHL.

11. Part B (Dose Expansion): Duration of Response (DoR) (Time Frame - Up to approximately 5 years):
To assess DoR of AZD7789 in patients with r/r cHL.

12. Part B (Dose Expansion): Duration of Complete Response (DoCR) (Time Frame - Up to approximately 5 years):
To assess DoCR of AZD7789 in patients with r/r cHL

13. Part B (Dose Expansion): Progression-free Survival (PFS) (Time Frame - Up to approximately 5 years):
To assess anti-tumor activity of AZD7789 in patients with r/r cHL.

14. Part B (Dose Expansion): Overall Survival (OS) (Time Frame - Up to approximately 5 years):
To assess anti-tumor activity of AZD7789 in patients with r/r cHL.

15. Part B (Dose Expansion): Number of patients with positive anti-drug antibodies against AZD7789 in serum (Time Frame - Up to 2 years):
To assess the presence of anti-drug antibodies for AZD7789 in treated patients with r/r cHL.

16. Part B (Dose Expansion): Maximum observed concentration (Cmax) (Time Frame - Up to 2 years):
To assess the Cmax of AZD7789 in patients with r/r cHL.

17. Part B (Dose Expansion): Area under the concentration-time curve (AUC) (Time Frame - Up to 2 years):
To assess AUC of AZD7789 in patients with r/r cHL.

18. Part B (Dose Expansion): Terminal elimination half-life (t½) (Time Frame - Up to 2 years):
To assess t½ of AZD7789 in patients with r/r cHL.

19. Part B (Dose Expansion): Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) (Time Frame - Up to 2 years of treatment):
Proportion of participants reporting different levels of presence/magnitude/interference (as applicable) of diarrhea, rash, and fatigue over time based on PRO-CTCAE will be evaluated.

20. Part B (Dose Expansion): Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Peds-PRO-CTCAE) (Time Frame - Up to 2 years of treatment):
Proportion of participants reporting different levels of presence/magnitude/interference (as applicable) of diarrhea, rash, and fatigue over time based on peds-PRO-CTCAE will be evaluated.

21. Part B (Dose Expansion): Patient Global Impression of Treatment Tolerability (PGI-TT) (Time Frame - Up to 2 years of treatment):
Proportion of participants reporting different levels of overall side-effect bother over time based on the PGI-TT.

22. Part B (Dose Expansion): European Organization for Research and Treatment of Cancer (EORTC) Item List (IL)XX QL2 (2-item global health-related quality of life (HRQoL)) (Time Frame - Up to 2 years of treatment):
Proportion of participants reporting different levels of quality of life/health over time based on the European Organization for Research and Treatment of Cancer Item List (EORTC) ILXX QL2 items will be evaluated.

Studien-Arme

  • Experimental: Cohort A: Dose Escalation
    Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive AZD7789.
  • Experimental: Cohort B1: Dose Expansion
    Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive AZD7789 once the recommended phase 2 dose (RP2D) has been determined.
  • Experimental: Cohort B2: Dose Expansion
    Patients with anti-PD-1/PD-L1 naïve r/r cHL will receive AZD7789 once the RP2D has been determined.

Geprüfte Regime

  • AZD7789:
    Patients will receive AZD7789 (PD-1/TIM-3 bispecific monoclonal antibody) via intravenous infusion.

Quelle: ClinicalTrials.gov


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