Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A in China

NCT03998345 | Unknown DMC

• 1 other identifier: SSGJ-609-UND-I-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A in the Patients with Locally advanced/Metastatic Solid Tumors in China.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Treatment-Emergent Adverse Events

  To access adverse events (AEs) per the NCI CTCAE 5.0.

  for 90 days

• The MTD

  Maximum Tolerated Dose， if any, and RP2D (s) for 609A will be determined.

  for 90 days

Secondary Outcomes (11)

• AUC

  for 90 days

• Cmax

  for 90 days

• t1/2

  for 90 days

• CL

  for 90 days

• ORR

  for 1 year

Study Arms (1)

609A group

EXPERIMENTAL

Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation Level cohort 1. Dose 1 mg/kg, Q3W, IV. Subjects 3-6； Dose Escalation Level cohort 2. Dose 3 mg/kg, Q3W, IV. Subjects 3-6； Dose Escalation Level cohort 3. Dose 200mg, Q3W, IV. Subjects 3-6； Dose Escalation Level cohort 4. Dose 10 mg/kg, Q3W, IV. Subjects 3-6. If 10mg/kg cannot be tolerated, add a dose level of 400mg to assess the tolerance

Drug: 609A

Interventions

609A DRUG

609A is a recombinant anti-PD-1 humanized IgG4 kappa antibody that targets the human PD-1

609A group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and willing to sign the Informed Consent Form(ICF).
• No limit gender .
• Age range: from 18 years to 70 years.
• Subjects with histologically or cytologically confirmed locally advanced-stage or metastatic tumor must have failed standard treatment (disease progression or intolerance) or lack of standard treatment. If there is a driver gene variant, the subjects must have failed the standard treatment for the driver gene, and there is no other standard treatment.
• Patients who had been previously treated for brain metastases, must have asymptomatic or radiographic/clinical stability and no need for steroid therapy of brain metastases to be enrolled in this study within 4 weeks prior to enrollment .
• According to RECIST1.1, Patients must have at least one measurable lesion (target or non-target).
• ECOG scores 0,1 or 2.
• Life expectancy ≥3 months
• Must have adequate organ function, prior to start of 609A, including the following:
• Bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.0 ×109/L; platelet count≥ 100 × 109/L; hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L;
• Hepatic: total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 3 × ULN (≤5 × ULN if with liverinvolvement)
• Renal: serum creatinine ≤1.5 times the ULN or estimated creatinineclearance ≥50mL/min (Cockroft and Gault formula).
• Coagulation tests INR≤ 2 (Exception: INR 2 to ≤ 3 is acceptable for subjects on Warfarin anticoagulation), activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
• Female patient with fertility or male patient whose partner has fertility should use one or more contraceptive methods for contraception from the screening period to five half-lives after the last treatment. These measures include, but are not limited to, oral or implantable injections of hormonal contraceptives; intrauterine birth control ring or placement of intrauterine system (IUS) hormone-releasing intrauterine device; or use of barrier methods such as condoms or septum and spermicide products. Women of childbearing potential must have a negative pregnancy test ≤ 72 hours prior to the first dose of study drug. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.

You may not qualify if:

• Subjects who meet any of the following criteria will not be enrolled:
• History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or excipients in 609A drug formulation.
• Subjects who had experienced severe allergic reactions after administration of other monoclonal antibodies
• Pregnant or nursing females
• Regarding previous anti-tumor therapy:
• Subjects who have received any anticancer drugs approved or investigational, including chemotherapy,hormonal therapy (Exceptions: hormone-replacement therapy, testosterone or oral contraceptives), biologic therapy, have stopped treatment for less than 3 weeks or 5 half-lives, whichever is longer, before first dose of 609A.
• Subjects who have stopped systemic radiation therapy less than 3 weeks before first dose of 609A, or local radiotherapy or radiation therapy for bone metastases less than 2 weeks before first dose of 609A. Therapeutic radiopharmaceuticals were taken within 8 weeks before first dose of 609A.
• Subjects who have received prior immunotherapies targeting T cell stimulation such as (e.g. anti-PD-1, anti- PD-L1 or anti-CTLA-4) ,have stopped treatment less than 3 months before first dose of 609A.
• The ADA antibody of anti-PD-1 drug in plasma was positive during screening.
• Subjects who have received immunogonists (such as interleukin-2 gamma interferon, oncolytic virus, mistletoe extract, etc.) or drugs known to interfere with major organ function (e.g., hypericin) , have stopped treatment less than 4 weeks or 5 half-lives, whichever is longer, before first dose of 609A.
• Subjects with severe chronic or active infections requiring systemic antimicrobial, antifungal, or antiviral treatment, including tuberculosis.
• HIV infection
• Active hepatitis B or C. HBV carriers without active disease (HBV DNA titer\< 1000 cps/mL or 200 IU/mL) or cured Hepatitis C (negative HCV RNA test) may been rolled
• Subjects with history of interstitial lung disease or noncommunicable pneumonia, or uncontrolled pulmonary fibrosis or acute pulmonary disease . Local interstitial pneumonia due to radiotherapy was excluded.
• Acute or chronic uncontrolled renal disease( Exception: Renal carcinoma, metastatic renal cancer), pancreatitis or liver disease (per investigator assessment).

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Cancer hospital Chinese academy of medical sceience

Beijing, Beijing Municipality, 100021, China

RECRUITING

Central Study Contacts

Gang Tong

CONTACT

+86- 21- 021-50793963; tonggang@3sbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: July 25, 2020
• Primary Completion: December 24, 2020
• Study Completion: December 30, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

CN (1)