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Solid TumorsPhase 1NCT03950297

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

A Phase 1 study testing 609A in people with Solid Tumors, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A in the Patients with Locally advanced/Metastatic Solid Tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
609A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
1 May 2019to 24 May 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all the following inclusion criteria to be eligible for participation in this study:
  • 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;
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  • 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.
  • According to RECIST1.1, the subject should have an assessable lesion (target lesion or non- target lesion)
  • According to RECIST1.1, the subject should have an assessable lesion (target lesion or non- target lesion) ECOG score 0, 1 or 2 point.

Who cannot join

  • 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
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  • 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.
  • Subjects who experienced immunotherapy-related adverse events (irAE) grade ≥ 3, or who had to discontinue prior anti-PD-1, anti-PD-L1, or CTL4 treatment due to irAEs of any grade.
  • Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, ECG QTcF (Fridericia)≥450 msec for male or QTcF (Fridericia)≥470 msec for female, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
  • Hypertension (defined as sustained systolic blood pressure> 160 mm Hg and / or post- diastolic blood pressure with antihypertensive drugs> 100 mmHg;
  • Any other serious underlying medical (e.g. uncontrolled diabetes mellitus, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of clotting disorders), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect subject compliance or place the subject at high risk from treatment-related complications.
  • Has received a live and attenuated vaccine within 28 days prior to the first dose of study drug.
  • Patients who had received treatment with any herbal or alternative therapies or Chinese prepared medicine within 7 days prior to the first dose of the studydrug.
  • Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded; these include but are not limited to subjects with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain- Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, hepatitis, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or antiphospholipidsyndrome.

Trial locations and contacts

1 site in 1 country.

Anthony Tolcher, MD contact

210-595-5670

atolcher@nextsat.com

United States1 site, 1 recruiting

  • NEXT Oncology Business Office

    San Antonio, Texas, 78229

    Aracely Cavazos, BBA

    Recruiting

Other trials in United States

About this study

Official title: A First-in-Human, Open-label, Phase 1 Dose-Escalation Study of 609A in Subjects With Locally Advanced / Metastatic Solid Tumors

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

Read the detailed description

This is a first-in-human (FIH), open-label, phase 1 dose-escalation study of 609A, a recombinant monoclonal anti-PD-1 antibody product, in subjects with Locally advanced/Metastatic Solid Tumors, who must have received, or be intolerant to all available approved or standard therapies known to confirm clinical benefit, or for whom no standard therapy exits.

Conditions
Solid Tumors
Being tested
609A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 609ADrug

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

Study groups in NCT03950297
Study groupRoleWhat they receive
609A groupExperimentalDose 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;
Receives: Drug: 609A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-Emergent Adverse Events

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

    Measured: for 90 Days

  2. The MTD

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

    Measured: for 90 Days

Secondary outcomes (10)

  1. AUC

    Area Under the Curve of 609A

    Measured: for 90 Days

  2. Cmax

    Maximum Plasma Concentration of 609A

    Measured: for 90 Days

  3. t½

    Half life of 609A in blood

    Measured: for 90 Days

  4. CL

    Plasma clearance of 609A

    Measured: for 90 Days

  5. ORR

    the rate of completely response [CR] and partial response [PR] patients

    Measured: for 1 Year

  6. DCR

    disease control rates of the patients with 609A

    Measured: for 1 Year

  7. PFS

    Progression-free survival of the patients with 609A

    Measured: for 1 Year

  8. DOR

    Duration of response of the patients with 609A

    Measured: for 1 Year

  9. OS

    overall survival of the patients with 609A

    Measured: for 1 Year

  10. Immunogenicity

    the presence of anti-609A antibody will be assessed

    Measured: for 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2019
  2. Study start1 May 2019
  3. Primary completion24 Oct 2020 (estimated)
  4. Study completion24 May 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03950297
Sponsor's protocol ID
SSGJ-609-UND-US-I-01
Status last verified
May 2019
First submitted
13 May 2019
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 609A in people with Solid Tumors, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anthony Tolcher, MD (210-595-5670, atolcher@nextsat.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-Emergent Adverse Events (time frame: for 90 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03950297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.

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