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This is a phase 1/2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy
This study will be conducted in 2 parts:
The Phase 1 part of the trial consists of a dose-escalation portion designed to evaluate the safety and tolerability of SCG142, and to identify the RP2D.
The Phase 2 part of the trial is designed to evaluate the preliminary efficacy of SCG142 in the same patient populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCG142 T cells | Experimental | This is a single arm study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCG142 | Biological | Autologous SCG142 cells infused on Day 0 after completion of lymphedepletion chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Phase 1) | Incidence of dose-limiting toxicities (DLTs) and occurrence of study related adverse events. | 2 years |
| Objective response rate (ORR) (Phase 2) | The proportion of patients with a complete response (CR) or partial response (PR) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) (Phase 1) | The proportion of patients with a complete response (CR) or partial response (PR) | 2 year |
| Duration of objective response (DOR) (Phase 1&2) | The time from the first occurrence of a confirmed response to disease progression or death from any cause |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SCG Cell Therapy | Contact | (65) 6829 7180 | clinicaltrials@scgcell.com |
| Name | Affiliation | Role |
|---|---|---|
| SCG Cell Therapy | SCG Cell Therapy Pte. Ltd. | Study Director |
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| Cyclophosphamide | Drug | for 3 consecutive days |
|
| Fludarabine | Drug | for 3 consecutive days |
|
| 2 year |
| Disease control rate (DCR) (Phase 1&2) | The proportion of patients with a CR, PR or stable disease (SD) | 2 year |
| Progression-free survival (PFS) (Phase 1&2) | The time from the date of the SCG142 administration to the first occurrence of a progressive disease (PD) or death from any cause | 2 year |
| Overall survival (OS) (Phase 1&2) | The time from date of the SCG142 administration to date of death of any cause | 2 year |
| Incidence of Treatment-Emergent Adverse Events (Phase 2) | TEAEs | 2 years |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D014846 | Vulvar Neoplasms |
| D014625 | Vaginal Neoplasms |
| D010412 | Penile Neoplasms |
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014845 | Vulvar Diseases |
| D014623 | Vaginal Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D010409 | Penile Diseases |
| D052801 | Male Urogenital Diseases |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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