A Phase I Clinical Study for Evaluating the Safety and Efficacy of MASCT-I in Patients With Advanced Solid Tumors

NCT03034304 | Terminated Phase 1

• 1 other identifier: HRYZ MASCT-I-1001
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to evaluate Safety and tolerability of MASCT-I in patients with advanced solid tumors, either alone or in combination with chemical drugs or in combination with PD1 antibody.

Conditions

Advanced Solid Tumors

Keywords

MASCT-I,DC,T cell; Advanced solid tumors

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events(Safety)

  All the local reactions, systemic reactions, adverse events and serious adverse events of all the patients will be collected from the informed consent to the end of the study.

  up to 96 weeks

Secondary Outcomes (7)

• Incidence of Treatment-Emergent Adverse Events(Safety)

  up to 96 weeks

• Disease Control Rate (DCR)

  up to 96 weeks

• Progression-Free Survival (PFS)

  up to 96 weeks

• Overall Survival (OS)

  up to 96 weeks

• Time to recurrence (TTR)

  up to 96 weeks

Study Arms (1)

MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody

EXPERIMENTAL

Group 1: MASCT-I alone; Group 2: Advanced urothelial carcinoma and cholangiocarcinoma treatment with MASCT-I alone,Advanced soft tissue sarcoma and osteosarcoma treatment with MASCT-I alone or combination with ifosfamide. In the event of disease progression, treatment with MASCT-I +PD1 antibody; Group 3: Advanced metastatic or recurrent urothelial carcinoma, soft tissue sarcoma/osteosarcoma, and cholangiocarcinoma that progressed after first line chemotherapy were treated with MASCT-I combined with PD1 antibody; Group 4: Recurrent metastatic solid tumors that had failed previous treatment with PD1 antibody were treated with MASCT-I + PD1 antibody; Group 5: Untreated advanced soft tissue sarcom treatment with MASCT-I+AI (Adriamycin+ifosfamide); Group 6: Untreated advanced urothelial carcinoma treatment with MASCT-I+GP/GC(Gemcitabine+cisplatin/ Gemcitabine+carboplatin);

Biological: MASCT-I; Drug: Ifosfamide; Drug: PD1 antibody; Drug: Adriamycin; Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin

Interventions

MASCT-I BIOLOGICAL

The final products of MASCT-I technology are dendritic cells (DC) and effector T cells

MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody

Ifosfamide DRUG

2g/m2/d, intravenous drip for 30min. Administration is conducted for continuous 5 days. After 4 weeks, the above cycle is repeated for 6 continuous cycles

MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody

PD1 antibody DRUG

200 mg/every two weeks ,four weeks is a cycle. Subjects were treated with MASCT-I combined with PD1 antibody until disease progression, MASCT-I intolerance or study completion. If PD1 antibody intolerance occurs, MASCT-I therapy alone will continue. MASCT-I and PD1 antibody are adminnistered according to their respective drug cycle without interfering with each other.

MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody

Adriamycin DRUG

60mg/m2, from the first day of each cycle, it is used for 1-2 days, intravenous drip. Repeat the above cycle after 4 weeks, no more than 8 cycles

MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody

Gemcitabine DRUG

1000 mg/m2, Intravenous drip for about 30 min, used on the first and eighth days of each cycle, and every 3-4 weeks as a cycle

MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody

Cisplatin DRUG

70mg/m2, Use on the first day of each chemotherapy cycle, intravenous drip for 30-120 min, and every 3-4 weeks as a cycle;

MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody

Carboplatin DRUG

5mg/ml/min, Use it on the first day of each chemotherapy cycle, intravenous drip for 30 minutes, and every 3-4 weeks as a cycle

MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody

Eligibility Criteria

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

You may qualify if:

• Age 18-70 at screening;
• Obtain written informed consent of the subject/legal representative prior to conducting any program related procedures, including evaluation during the screening period;
• Scored 0 -1 on ECOG;
• Life expectancy ≥6 months;
• Cardiopulmonary function is basically normal;
• Results of blood test and biochemistry at baseline meeting the following criteria:Hemoglobin≥85g/L,Leucocyte≥3.0×109/L,Absolute neutrophil count(ANC)≥1.5×109/L,Trombocyte≥70×109/L,ALT/AST ≤ 2.5×ULN or ≤ 5×ULN for patients with hepatic metastases, ALP≤2.5 times of upper limit of normal, Serum total bilirubin \< 1.5×ULN,Serum urea nitrogen and creatinine ≤ 1.5×ULN,patients with urothelial carcinoma,Serum urea nitrogen and creatinine ≤ 2.5×ULN, Serum albumin ≥30g/L
• For the first group of subjects, the following criteria should be met:
• Patients who suffer from advanced (unresectable) or recurrent solid tumors (only limited to bladder cancer and soft tissue sarcoma) confirmed by histology and cytology and are treated unsuccessfully with various standard therapies;
• According to RECIST1.1 criteria, there must be one measurable focus;
• Time interval between end of other anti-tumor measures and this study treatment is at least 1 month;
• For the second group of subjects, the following criteria should be met:
• Urothelial carcinoma: histologically or cytologically confirmed that gemcitabine + platinum-based first-line chemotherapy achieved clinical benefit after 4-6 cycles of advanced recurrence or metastasis;
• Soft tissue sarcoma or osteosarcoma: Subjects who histologically or cytologically demonstrated clinical benefit after at least 4 cycles of doxorubicin-based first-line chemotherapy following advanced recurrence or metastasis. For some subjects who are intolerant or insensitive to chemotherapy, screening can also be conducted after other first-line treatment regiments achieve clinical benefit.
• Cholangiocarcinoma: Histologically or cytologically confirmed, first-line treatment after advanced recurrence or metastasis is beneficial.
• Note: Clinical benefit is defined as complete response (CR), partial response (PR), or disease stabilization (SD). The disease stabilizes for more than 2 months.

You may not qualify if:

• Subjects have clinically manifested central nervous system metastases (such as brain edema, need for hormonal intervention, or progression of brain metastases). Subjects who have received previous treatment for brain or meningeal metastasis, such as clinical stability (MRI) for at least 2 months, and have ceased systemic sex hormone therapy (\>10mg/ day prednisone or other therapeutic hormones) for more than 2 weeks may be included;
• Subjects are receiving immunosuppressive, or systemic, or absorbable local hormone therapy for immunosuppression purposes (\>10mg/ day prednisone or other therapeutic hormones) and continue to receive such therapy within 2 weeks prior to enrollment;
• Subjects are taking immunomodulator drugs and continue to use them within 2 weeks prior to enrollment;
• Subjects have received MASCT or other cellular immunotherapy or PD1 antibody therapy in the previous year (subjects in the fourth group are not limited to PD1 antibody therapy);
• Subject has any active autoimmune disease or a history of autoimmune disease;
• The subject has active tuberculosis;
• Subject has hepatitis C or HIV infection, or syphilis infection;
• Patients with gastrointestinal stromal tumor, Ewing sarcoma and rhabdomyosarcoma
• Patients with recurrence or metastasis during the adjuvant treatment after radical surgery or within 6 months after the end of the treatment (only for patients in Group 5 and Group 6):
• Those who have used targeted therapy, radiotherapy, immunotherapy or other treatment schemes with clear anti-tumor effect within 4 weeks before enrollment, such as arrotinib, gemcitabine and traditional Chinese medicine; However, if the focus of radiotherapy is not a target focus or there is clear progress after radiotherapy, it can be considered to be included in the group (only for the fifth and sixth groups of subjects);
• Those who are not suitable for treatment with A1 scheme (only for the fifth group of subjects)
• Hearing impairment with CTCAE grade\>2 (for the sixth group)
• Peripheral neuropathy with CTCAE grade \>2 (such as sensory degeneration, sensory abnormality, including tingling sensation) (for the sixth group);
• The investigators believed that the subjects were not suitable for chemotherapy containing platinum or gemcitabine (for the sixth group);

Sponsors & Collaborators

• HRYZ Biotech Co.: lead

Study Sites (9)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Location

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Zhejiang Tumor Hospita

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Ifosfamide; spartalizumab; Doxorubicin; Gemcitabine; Cisplatin; Carboplatin

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Ruihua Xu, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

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: December 26, 2016
• First Posted: January 27, 2017
• Study Start: February 22, 2017
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: July 24, 2025

Record last verified: 2025-05

Locations

CN (9)