A clinical study of MK-6070 and ifinatamab deruxtecan in people with small cell lung cancer (MK-6070-002)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

12 Mar 2025 → ongoing

Decision date (initial)

2025-03-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC · Daiichi Sankyo

External identifiers

EU CT number

2024-517926-25-00

WHO UTN

U1111-1313-1108

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Therapy, Efficacy, Pharmacokinetic

1. Part 1: To evaluate the safety and tolerability of MK-6070 in combination with I-DXd administered at various schedules or I-DXd monotherapy administered every 2 weeks
2. Part 1: To evaluate ORR, per RECIST 1.1, of MK-6070 in combination with I-DXd administered at various schedules or I-DXd monotherapy administered every 2 weeks
3. Part 2: To evaluate safety and tolerability of MK-6070 monotherapy
4. Part 3: To evaluate safety and tolerability of MK-6070 in combination with durvalumab

Secondary objectives 14

1. Part 1: To evaluate DOR, per RECIST 1.1, of MK-6070 in combination with I-DXd administered at various schedules or I-DXd monotherapy administered every 2 weeks
2. Part 1: To evaluate PFS, per RECIST 1.1, of MK-6070 in combination with I-DXd administered at various schedules or I-DXd monotherapy administered every 2 weeks
3. Part 1: To characterize the PK profile of MK-6070 and I-DXd in combination or I-DXd monotherapy administered every 2 weeks
4. Part 1: To evaluate the immunogenicity of MK-6070 and I-DXd in combination or I-DXd monotherapy administered every 2 weeks
5. Part 2: To evaluate ORR, per RECIST 1.1, of MK-6070 monotherapy in participants of China Monotherapy Cohort (Arm 5) and in participants of Reduced Required Monitoring Cohort (Arm 6)
6. Part 2: To evaluate DOR, per RECIST 1.1, of MK-6070 monotherapy in participants of China Monotherapy Cohort (Arm 5) and in participants of Reduced Required Monitoring Cohort (Arm 6)
7. Part 2: To evaluate PFS, per RECIST 1.1, of MK-6070 monotherapy in participants of Reduced Required Monitoring Cohort (Arm 6)
8. Part 2: To characterize the PK profile of MK-6070 as monotherapy
9. Part 2: To evaluate the immunogenicity of MK-6070 monotherapy
10. Part 3: To evaluate ORR, per RECIST 1.1, of MK-6070 in combination with durvalumab
11. Part 3: To evaluate DOR, per RECIST 1.1, of MK-6070 in combination with durvalumab
12. Part 3: To evaluate PFS, per RECIST 1.1, of MK-6070 in combination with durvalumab
13. Part 3: To evaluate PK profile of MK-6070 and durvalumab
14. Part 3: To evaluate the immunogenicity of MK-6070 and durvalumab

Conditions and MedDRA coding

Small cell lung cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Has histologically or cytologically confirmed small cell lung cancer (SCLC) that is extensive stage defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy
2. Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample
3. Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)

Exclusion criteria 22

1. Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
2. History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis
3. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
4. Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART
5. History within 6 months before the first dose of study intervention of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association > class II), and/or uncontrolled cardiac arrhythmia
6. History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
7. Active clinically significant infection requiring systemic therapy
8. History of allogeneic tissue/solid organ transplant
9. History of leptomeningeal disease
10. Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
11. Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention
12. Known additional malignancy that is progressing or has required active treatment within the past 3 years
13. Untreated or symptomatic brain metastases
14. Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive in the setting of associated signs/symptoms), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive and/or detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA]), or hepatitis C (hepatitis C virus [HCV] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible.
15. Part 1 only: Radiation therapy to the lung >30 Gy within 6 months before the start of study intervention
16. Part 1 only: Abdominal radiation within 4 weeks before start of study intervention
17. Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone [LHRH]) within 2 weeks before start of study intervention
18. Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer
19. Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention
20. Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention
21. Part 1 only: Clinically significant corneal disease
22. Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Number of Participants Who Experience an Adverse Event (AE)
2. Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
3. Number of Participants Who Discontinue Study Intervention Due to an AE
4. Part 1: Objective Response Rate (ORR)

Secondary endpoints 49

1. Part 1, Part 2 (Arm 5 and Arm 6), and Part 3 (Arm 7): Duration of Response (DOR)
2. Part 1, Part 2 (Arm 6), and Part 3 (Arm 7): Progression-Free Survival (PFS)
3. Part 2 (Arm 5 and Arm 6) and Part 3 (Arm 7): ORR
4. Maximum Concentration (Cmax) of gocatamig
5. Cmax of ifinatamab deruxtecan (I-DXd)
6. Cmax of Anti-B7-H3 Antibody
7. Cmax of Deruxtecan (DXd)
8. Cmax of durvalumab
9. Time to maximum concentration (Tmax) of gocatamig
10. Tmax of I-DXd
11. Tmax of Anti-B7-H3 Antibody
12. Tmax of DXd
13. Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of gocatamig
14. AUCt of I-DXd
15. AUCt of Anti-B7-H3 Antibody
16. AUCt of DXd
17. erminal Half-Life (t1/2) of gocatamig
18. t1/2 of I-DXd
19. t1/2 of Anti-B7-H3 Antibody
20. t1/2 of DXd
21. Steady State Maximum Concentration (Cmax,ss) of gocatamig
22. Cmax,ss of I-DXd
23. Cmax,ss of Anti-B7-H3 Antibody
24. Cmax,ss of DXd
25. Cmax,ss of durvalumab
26. Steady State Ctrough (Ctrough,ss) of gocatamig
27. Ctrough,ss of I-DXd
28. Ctrough,ss of Anti-B7-H3 Antibody
29. Ctrough,ss of DXd
30. Ctrough,ss of durvalumab
31. Steady State Time to Maximum Concentration (Tmax,ss) of gocatamig
32. Tmax,ss of I-DXd
33. Tmax,ss of Anti-B7-H3 Antibody
34. Tmax,ss of DXd
35. Area Under the Steady State Concentration-Time Curve Over Dosing Interval t (AUCt,ss) of gocatamig
36. AUCt,ss of I-DXd
37. AUCt,ss of Anti-B7-H3 Antibody
38. AUCt,ss of DXd
39. 39. Steady state t1/2 (t1/2,ss) of gocatamig
40. t1/2,ss of I-DXd
41. t1/2,ss of Anti-B7-H3 Antibody
42. t1/2,ss of DXd
43. Accumulation Ratio (AC) of gocatamig
44. AC of I-DXd
45. AC of Anti-B7-H3 Antibody
46. AC of DXd
47. Incidence of Anti-Drug Antibodies (ADAs) Against gocatamig
48. Incidence of ADAs Against I-DXd
49. Incidence of ADAs against durvalumab

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Ann Gramza

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Ann Gramza

Third parties 11

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications