ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors

Adagene

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced/Metastatic Solid Tumors

Treatments: Biological: ADG126-ADG106; Biological: ADG126-anti PD1; Biological: ADG126 Mono

Study type: Interventional

Funder types: Industry

Identifiers

NCT04645069

ADG126-1001

Details and patient eligibility

About

ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .

Full description

ADG126 is a novel anti-CTLA-4 fully human IgG1 antibody prodrug that is modified with Adagene Safebody technology to control the activation of anti-CTLA4 activity.ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb which is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG126 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Adults ≥18 years of age.
2. ECOG performance status 0 or 1.
3. Estimated life expectancy of more than 12 weeks .
4. Patients with advanced or metastatic solid tumors, confirmed by histologically or pathologically documented, who have progressed after all standard therapies, or for whom no further standard therapy exists.
5. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
6. Adequate organ function.
7. Meets the additional tumor type requirements as specified in Protocol.

Exclusion Criteria:

1. Treatment with any investigational drug within washout period.

2. Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)

3. History of significant immune-mediated AE.

4. Central nervous system (CNS) disease involvement.

5. Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation

6. Clinically significant cardiac disease.

7. Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.

8. Patients who received:

   1. A COVID-19 vaccine within 7 days of Cycle 1 Day 1.
   2. Live vaccines or live-attenuated vaccines within 28 days prior to Cycle 1 Day 1.

9. Known active infection of HBV/BCV/HIV.

10. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (>10 mg/day prednisone or equivalent).

11. Second primary malignancy not in remission for greater than 3 years.

12. History(within the last 5 years) or risk of autoimmune disease.

13. Pregnant or breastfeeding females.

14. Childbearing potential who does not agree to the use of contraception during the treatment period.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

58 participants in 6 patient groups

ADG126 mono dose escalation

Experimental group

Description:

ADG126 monotherapy dose escalation will be traditional 3+3 cohort design.

Treatment:

Biological: ADG126 Mono

ADG126 mono dose expansion

Experimental group

Description:

Monotherapy dose expansion is designed to evaluate the preliminary antitumor activity of ADG126 at RP2D or the doses approved by the SRC.

Treatment:

Biological: ADG126 Mono

ADG126-anti PD1 drug dose escalation

Experimental group

Description:

Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.

Treatment:

Biological: ADG126-anti PD1

ADG126-anti PD1 drug dose expansion

Experimental group

Description:

Combination therapy expansion will commence at RP2D or the dose approved by the SRC.

Treatment:

Biological: ADG126-anti PD1

ADG126-ADG106 dose escalation

Experimental group

Description:

Combination therapy will commence at a dose level lower than the cleared dose from the monotherapy dose escalation arms and approved by the SRC.

Treatment:

Biological: ADG126-ADG106

ADG126-ADG106 dose expansion

Experimental group

Description:

Combination therapy expansion will commence at RP2D or the dose approved by the SRC.

Treatment:

Biological: ADG126-ADG106