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

NCT03950297 | Unknown Phase 1 FDA Drug

• 1 other identifier: SSGJ-609-UND-US-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

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Treatment-Emergent Adverse Events

  To monitor 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 (10)

• AUC

  for 90 Days

• Cmax

  for 90 Days

• t½

  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;

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+
• 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).
• Male or female ≥ 18years.
• Subjects with histologically or cytologically confirmed advanced-stage or metastatic tumor must have received, or be intolerant to all available approved or standard therapies known to confirmed clinical benefit, or for whom standard therapy does not exist.
• 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 \[http://www.mdcalc.com/creatinine-clearance-cockcroft-gault-equation/\]).
• Coagulation tests INR≤ 2 (Exception: INR 2 to ≤ 3 is acceptable for subjects onWarfarin anticoagulation), activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
• Regarding prior anti-tumortherapy:
• Subjects who have received any anticancer drugs approved or investigational, including chemotherapy, immune therapy, hormonal therapy (Exceptions: hormone-replacement therapy, testosterone or oral contraceptives), biologic therapy, must have stopped treatment at least 3 weeks, or five half-lives, whichever is shorter, before first dose of 609A.
• Generalized radiation therapy must have stopped 3 weeks before first dose of 609A, or local radiotherapy or radiation therapy for bone metastases must have stopped 2 weeks before first dose of 609A. No therapeutic radiopharmaceuticals are 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) must have stopped treatment for at least 4 weeks before first dose of 609A.
• 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 cannot be enrolled: Life expectancy \< 3 months.
• Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of the residual hair loss;
• Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of the residual hair loss; Any involvement of CNS excluded except: Based on screening brain magnetic resonance imaging (MRI), patients must have one of the following:
• No evidence of brain metastases or has to be clinically stable for at least 4 weeks
• Untreated brain metastases not needing immediate localtherapy
• Pregnant or nursing females
• Subjects who have had major surgery within the 21-days from the screening;
• Subjects with history of interstitial lung disease or idiopathic pulmonary fibrosis or unresolved active or chronic inflammatory pulmonary disease are excluded. Subjects with a history of radiation pneumonitis which has resolved areeligible.
• 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.
• History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosisdisease.
• History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or excipients in 609A drug formulation.
• Acute or chronic uncontrolled renal disease, pancreatitis or liver disease (per investigator assessment).
• Subjects with any type of primary immunodeficiencies will be excluded from thestudy.
• Subjects with condition requiring systemic treatment with either corticosteroids (\>15 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days before the planned first dose of study drug. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent are permitted in the absence of activeautoimmune disease. Ophthalmologic, nasal and intra-articular injections of steroids areacceptable.

Sponsors & Collaborators

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

Study Sites (1)

NEXT Oncology Business Office

San Antonio, Texas, 78229, United States

RECRUITING

Central Study Contacts

Anthony Tolcher, MD

CONTACT

210-595-5670; atolcher@nextsat.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: May 1, 2019
• Primary Completion: October 24, 2020
• Study Completion: May 24, 2022
• Last Updated: April 3, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)