A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)

Browse trials for

• Neoplasms 9,365

Keywords

• Solid Tumors
• Mocertatug rezetecan
• Mo-Rez
• GSK5733584
• BEHOLD-1

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 675 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• Experimental
  Part 1: Dose Escalation

  Participants with advanced solid tumors who are refractory or intolerant to established standard therapies

  Drug: Mocertatug rezetecan

• Experimental
  Part 2: Dose Expansion

  Participants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC)

  Drug: Mocertatug rezetecan

Interventions

• DrugMocertatug rezetecan

  Mocertatug rezetecan will be administered

Primary outcomes

1. Part 1: Number of participants with dose limiting toxicity (DLT)

   Time frame: Up to 21 days

2. Part 2-Confirmed Objective Response Rate (ORR) assessed by investigator

   ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

   Time frame: Up to approximately 28 months

Secondary outcomes

1. Part 1 and 2: Maximum observed concentration (Cmax) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin

   Time frame: Up to approximately 31 months

2. Part 1 and 2: Time to reach Cmax (Tmax) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin

   Time frame: Up to approximately 31 months

3. Part 1 and 2: Area under the concentration-time curve (AUC) of Mocertatug Rezetecan and its components: conjugated antibody, total antibody, and small molecule toxin

   Time frame: Up to approximately 31 months

4. Part 1- Confirmed Objective Response Rate assessed by investigator

   ORR is defined as the proportion of participants with at least one confirmed CR or PR as defined by RECIST 1.1

   Time frame: Up to approximately 31 months

5. Part 1 and 2: Duration of response (DoR) assessed by investigator

   DoR is defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause

   Time frame: Up to approximately 31 months

6. Part 1 and 2: Progression-free survival (PFS) assessed by investigator

   PFS is defined as the time interval between randomization (or from the first dose of the intervention) and the first documented disease progression or death due to any cause (whichever occurs first).

   Time frame: Up to approximately 31 months

7. Part 1 and 2: Number of participants with treatment-emergent Anti-drug antibodies (ADA) / Neutralizing antibody (NAb)

   Time frame: Up to approximately 31 months

8. Part 1 and 2: Titers of ADA to Mocertatug Rezetecan

   Time frame: Up to approximately 31 months

9. Part 1 and 2: Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

   Time frame: Up to approximately 31 months

10. Part 1 and 2: Change from baseline in body temperature (degree Celsius)

    Time frame: Baseline (Day -1) and up to approximately 31 months

11. Part 1 and 2: Change from baseline in respiratory rate (breaths per minute)

    Time frame: Baseline (Day -1) and up to approximately 31 months

12. Part 1 and 2: Change from baseline in pulse rate (beats per minute)

    Time frame: Baseline (Day -1) and up to approximately 31 months

13. Part 1 and 2: Change from baseline in blood pressure [millimetres of mercury (mmHg)]

    Time frame: Baseline (Day -1) and up to approximately 31 months

14. Part 1 and 2: Change from baseline in weight [kilogram (kg)]

    Time frame: Baseline (Day -1) and up to approximately 31 months

15. Part 1 and 2: Change from baseline in white blood cell count (cells per microliter)

    Time frame: Baseline (Day -1) and up to approximately 31 months

16. Part 1 and 2: Change from baseline in hemoglobin (grams per deciliter)

    Time frame: Baseline (Day -1) and up to approximately 31 months

17. Part 1 and 2: Change from Baseline in Platelet count (cells per microliter)

    Time frame: Baseline (Day -1) and up to approximately 31 months

18. Part 1 and 2: Change from Baseline in Red Blood Cell Count (RBC) (million cells per microliter)

    Time frame: Baseline (Day -1) and up to approximately 31 months

19. Part 1 and 2: Change from Baseline in haematocrit (Proportion of red blood cells in blood)

    Time frame: Baseline (Day -1) and up to approximately 31 months

20. Part 1 and 2: Change from Baseline in Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)

    Time frame: Baseline (Day -1) and up to approximately 31 months

21. Part 1 and 2: Change from Baseline in Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium Direct Bilirubin and Total Bilirubin (milligrams per decilitre)

    Time frame: Baseline (Day -1) and up to approximately 31 months

22. Part 1 and 2: Change from Baseline in AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)

    Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed

    Time frame: Baseline (Day -1) and up to approximately 31 months

23. Part 1 and 2: Change from baseline in Total Protein and Albumin (Grams per deciliter)

    Time frame: Baseline (Day -1) and up to approximately 31 months

24. Part 1 and 2: Change from baseline in Amylase and Lipase (Units per liter)

    Time frame: Baseline (Day -1) and up to approximately 31 months

25. Part 1 and 2: Change from baseline in Estimated glomerular filtration rate (eGFR) (milliliter per minute)

    Time frame: Baseline (Day -1) and up to approximately 31 months

26. Part 1 and 2: Change from baseline in Prothrombin Time (PT), Partial thromboplastin time (PTT) or Activated Partial Thromboplastin Time (aPTT) (seconds)

    Time frame: Baseline (Day -1) and up to approximately 31 months

27. Part 1 and 2: Change from baseline in liver panel parameter: International Normalized Ratio (INR)

    Time frame: Baseline (Day -1) and up to approximately 31 months

28. Part 1 and 2: Change from baseline in routine urine tests: Leukocyte esterase

    Leukocyte esterase measured as negative or positive

    Time frame: Baseline (Day -1) and up to approximately 31 months

29. Part 1 and 2: Change from baseline in routine urine tests: Occult blood (10^9 Cells Per Liter)

    Time frame: Baseline (Day -1) and up to approximately 31 months

30. Part 1 and 2: Change from baseline in routine urine tests: potential of hydrogen (pH) value

    Time frame: Baseline (Day -1) and up to approximately 31 months

31. Part 1 and 2: Change from baseline in routine urine tests: Protein and bilirubin (Grams Per Liter)

    Time frame: Baseline (Day -1) and up to approximately 31 months

32. Part 1 and 2: Change From Baseline in routine urine tests: Specific Gravity (Ratio)

    Time frame: Baseline (Day -1) and up to approximately 31 months

33. Part 1 and 2: Change from baseline in CA-125 tumor marker among ovarian cancer participants [units per milliliter (U/mL)]

    Time frame: Baseline (Day -1) and up to approximately 31 months

34. Part 1 and 2: Change from baseline in Thyroid stimulating hormone (TSH) [microunits per milliliter (µU/mL)]

    Time frame: Baseline (Day -1) and up to approximately 31 months

35. Part 1 and 2: Change from baseline in free thyroxine (T4) [nanograms per deciliter (ng/dL)]

    Time frame: Baseline (Day -1) and up to approximately 31 months

36. Part 1 and 2: Change from baseline in Electrocardiogram (ECG) readings [milliseconds (msec)]

    Time frame: Baseline (Day -1) and up to approximately 31 months

37. Part 1 and 2: Change from baseline in Left ventricular ejection fraction (LVEF) [Percentage]

    Time frame: Baseline (Day -1) and up to approximately 31 months

38. Part 1 and 2: Change from baseline in Eastern Cooperative Oncology Group Performance Scale (ECOG PS) score

    ECOG PS is used for measuring how the disease impacts a patient's daily living abilities. The grades for the scale range from 0 (fully active) to 5 (dead), with increasing severity.

    Time frame: Baseline (Day -1) and up to approximately 31 months

39. Part 2: Overall Survival (OS)

    OS is defined as the time interval between the date of randomization (or from the first dose of the investigational product) and the date of death due to any cause

    Time frame: Up to approximately 31 months

40. Part 2-Confirmed Objective Response Rate (ORR) assessed by BICR

    ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Time frame: Up to approximately 31 months

41. Part 2: Duration of response (DoR) assessed by BICR

    DoR is defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause

    Time frame: Up to approximately 31 months

42. Part 2: Progression-free survival (PFS) assessed by BICR

    PFS is defined as the time interval between randomization (or from the first dose of the intervention) and the first documented disease progression or death due to any cause (whichever occurs first).

    Time frame: Up to approximately 31 months

Individual participant data

Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Supporting information: Study protocol, Sap, Icf, Csr