Study of NIB101 in Participants With Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title:

An Open-Label Non-Randomized Phase 1 Dose Escalation and Dose Expansion Study of NIB101 in Participants With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192174
• Other study ID #: NIB101-01
• Status: Recruiting
• Phase: Phase 1
• Start date: January 24, 2022
• Est. completion date: February 29, 2028

Study information

• Verified date: April 2023
• Source: Noile-Immune Biotech, Inc
• Contact: Clinical Trial Information Contact
• Phone: +81-3-5843-7819
• Email: dev[@]noile-immune.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

NIB101-01 study is an open-label, non-randomized Phase 1 study in participants with GM2 positive advanced solid tumor, who failed to available standard of cares to evaluate the safety and tolerability of NIB101.

Description:

The screening begins by signing the informed consent form and determining the participant's initial eligibility. Alternatively, in advance, the prescreening enables participants to confirm GM2 expression using the archived samples by signing the prescreening ICF prior to the screening. After the consent is obtained and the eligibility of participants is confirmed, the participant will undergo apheresis. Lymphodepleting chemotherapy will be administered prior to NIB101 infusion. After manufacturing of NIB101, participants will receive a single dose of NIB101 intravenously on Day 0 and be followed for safety and efficacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: February 29, 2028
• Est. primary completion date: February 29, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participant with histologically or cytologically confirmed solid tumor.

2. Participant who failed or are intolerable to available standard of cares (regardless of the number of prior lines of therapy) at the investigator's discretion.

3. Participant whose tumor tissues express GM2 membrane as determined by immunohistochemistry.

4. Participant who has measurable lesions.

5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

6. Life expectancy >=12 weeks from the signing screening ICF.

7. Participant with adequate organ functions.

8. Participant who can undergo apheresis at the investigator's discretion.

9. Participant must agree to use adequate contraception methods

10. Participant who is willing to sign a written informed consent.

Exclusion Criteria:

1. Active brain metastasis on the screening MRI (in case of MRI contradiction, CT is acceptable)

2. Participant with an active, known or suspected autoimmune disease requiring immune suppressive agents other than hormonal replacement therapy.

3. Prior malignancy (other than targeted GM2 positive malignancy) within the previous 3 years the signing screening ICF.

4. Suspected malignant lymphoma or leukemia

5. Participant with known or suspected interstitial pneumonia

6. Active infections requiring treatments

7. Participant with an active, known or suspected gangliosidosis.

8. Other concurrent serious diseases that may interfere with planned study intervention per investigator's discretion.

9. Prior treatment with engineered T-cell therapy/gene therapy.

10. Prior treatment with any GM2, Interleukin-7 (IL-7) or Chemokine (C-C motif) ligand 19 (CCL19) targeted therapy.

11. Participant with a condition requiring systemic treatment with either corticosteroids (>= 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to apheresis. Inhaled or topical steroids, and adrenal replacement steroid doses <10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

12. Participant with adverse events due to prior therapy have not recovered to grade 1 or baseline, except for non-clinically significant adverse events at the investigator's discretion such as alopecia.

13. Anti-neoplasm treatment within 14 days prior to apheresis

14. Radiation therapy within 14 days prior to apheresis

15. Participant currently requiring ganciclovir, valganciclovir, and so on (the drug that provides HSV-TK substrate) treatment. Participants currently receiving prophylaxis treatment can be enrolled if the prophylaxis treatment is completed before apheresis.

16. Major surgery within 4 weeks prior to screening informed consent.

17. Prior treatment with any investigational study drug/investigational study cell and gene therapies within 28 days before signing screening ICF.

18. Positive human immunodeficiency virus (HIV) and/or Human T-cell leukemia virus-1 (HTLV-1) antibody test on the screening prior to apheresis.

19. Positive Hepatitis B surface (HBs) antigen or Hepatitis C virus (HCV) antibody test on the screening prior to apheresis. Participant who has positive HBs antibody or Hepatitis B core (HBc) antibody can be enrolled if Hepatitis B virus (HBV)-DNA is undetectable.

20. Any symptoms of suspected syphilis

21. Pregnant or breastfeeding

22. History of allergy or hypersensitivity to components of NIB101 or materials used for manufacturing NIB101.

23. Hypersensitivity or contraindicated to study intervention components.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• NIB101
NIB101

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo Ku	Tokyo
Japan	National Cancer Center Hospital East	Kashiwa	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Noile-Immune Biotech, Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities	Specific adverse events defined in the protocol and related to NIB101 infusion	28 days after NIB101 infusion
Primary	Adverse Events	Number of participants with adverse events	2 years from NIB101 infusion
Secondary	Objective Response	Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) determined by the investigator per RECIST version 1.1 or modified RECIST	2 years from NIB101 infusion
Secondary	Overall Response Rate	Percentage of subjects who achieved PR or better	2 years from NIB101 infusion
Secondary	Disease Control Rate	Percentage of subjects who achieved SD or better	2 years from NIB101 infusion
Secondary	Duration of Response	Time from first documentation of response (PR or better) to first documentation of disease progression or death from any cause	2 years from NIB101 infusion
Secondary	Time To Response	Time from NIB101 infusion to the initial documented response (PR or better)	2 years from NIB101 infusion
Secondary	Progression Free Survival	Time from NIB101 infusion to the date of disease progression or death from any cause.	2 years from NIB101 infusion
Secondary	Overall Survival	Time from NIB101 infusion to time of death due to any cause	2 years from NIB101 infusion
Secondary	Pharmacokinetics (Cmax)	Maximum peak of NIB101	2 years from NIB101 infusion
Secondary	Pharmacokinetics (Tmax)	Time to maximum peak of NIB101	2 years from NIB101 infusion
Secondary	Pharmacokinetics (T1/2)	Half life of NIB101	2 years from NIB101 infusion
Secondary	Pharmacokinetics (Clast)	Concentration of last quantified NIB101	2 years from NIB101 infusion
Secondary	Pharmacokinetics (Tlast)	Time of Clast observed	2 years from NIB101 infusion
Secondary	Pharmacokinetics (AUC)	Area under the curve of NIB101	2 years from NIB101 infusion
Secondary	Immunogenicity	Evaluation of an anti-CAR antibody response	2 years from NIB101 infusion
Secondary	Replication Competent Retrovirus (RCR)	Number of cases of positive RCR	2 years from NIB101 infusion