Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Stomach Neoplasms

Carcinoma

Lung Neoplasms

Adenomatous Polyposis Coli

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stomach Diseases

Neoplastic Processes

Polyps

Adenomatous Polyps

Adenoma

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Stomach Cancer

Familial Adenomatous Polyposis

MYH-associated Polyposis

Solid Tumors with Any WNT-Pathway Activating Mutations (WPAMs) or Microsatellite Stable (MSS) Colorectal Cancer (Irrespective of WPAM Status)

Microsatellite Stable Colorectal Cancer (Irrespective of WPAM Status)

Non-Small Cell Lung Cancer with a WNT-Pathway Activating Mutation (WPAM) in Adenomatous Polyposis Coli (APC) or Beta-Catenin

Gastric Cancer/Gastroesophageal Junction Carcinoma (GEJ) with a WNT-Pathway Activating Mutation (WPAM) in Adenomatous Polyposis Coli (APC) or Beta-Catenin

Solid Tumors with Any WNT-Pathway Activating Mutations (WPAMs)

FOG-001 will be administered IV once weekly at assigned doses in continuous cycles of 28 days

FOG-001

FOG-001 will be administered IV once weekly at the RP2D dose in continuous cycles of 28 days

Clinical Trial Inquiries

Sunil Sharma, MD

Michael Cecchini, MD

Samuel Klempner, MD

Moh'd Khushman, MD

Shivaani Kummar, MD

Meredith S Pelster, MD

Jordi Rodon Ahnert, MD/PhD

Kyriakos Papadopoulos, MD

Keith Orford, MD, PhD

The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.

This first-in-human, Phase 1/2, multicenter, open-label, non-randomized dose escalation and expansion study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of FOG-001 in participants with locally advanced or metastatic solid tumors. FOG-001 is a first-in-class direct inhibitor of Beta-catenin, which functions by blocking its interaction with the T-cell factor (TCF) family of transcription factors.

FOG-001 in Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors

Number and severity of treatment emergent adverse events as assessed by CTCAE v5.0

The rate of objective responses (Partial \& Complete) using RECIST v1.1

Rate of Dose Limiting Toxicities (DLTs) across dose levels

Change in tumor Myc expression (on-study compared to baseline)

Best response to treatment using RECIST v1.1

Time from initial objective response (partial response or complete response) to disease progression

Progression Free Survival (PFS) using RECIST v1.1

Fog Pharmaceuticals, Inc.

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Vaccines

BCG Vaccine

Immunologic Factors

Adjuvants, Immunologic

9vHPV Vaccine 1.0 mL add into BCG Organism 50 MG

* By the percutaneous route with the multiple puncture device
* 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix

9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use

HAN XU, MD/PhD/FAPCR

Conducting an early phase clinical trial to assess HPV Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of HPV patients.

1. Treat Infection of Multiple HPV Virus Strains via Trained Immunity.
2. Activate human HPV Antigen Presentation Reaction.
3. The human antigen presenting cells (APCs) can treat the HPV virus protein antigens into small peptide fragments, and then clear HPV virus in vivo.

* Conducting an early phase clinical trial to assess HPV Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of HPV patients
* 20 Cervical HPV Infection Patients
* Positive testing HPV by standard PCR assay
* HPV infection without symptoms
* No clinical signs indicative of oncology
* PPD negative participant is 10 TU skin test reading \< 5 mm induration at 48 hours
* Our trial duration will be 12-week duration.
* 9vHPV Vaccine 1.0 mL plus BCG Organism 50 MG Mix
* By the percutaneous route with the multiple puncture device
* Our trial duration will be 12-week duration
* Negative testing HPV by standard PCR assay after percutaneous 21 days

Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV

Conducting an Early Phase Clinical Trial to Assess for HPV Antigen Presentation Therapeutic Biological Product Mix Activity That Suggests the Potential for Clinical Benefits of HPV Patients.

Negative testing HPV by standard PCR assay after percutaneous 21 days

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair

Recurrence

Antineoplastic Agents

Nivolumab

Atezolizumab

Antibodies

Immune Checkpoint Inhibitors

Immunomodulating Agents

Ipilimumab

Immunoglobulins

Antibodies, Blocking

Antineoplastic Agents, Immunological

In Part 1, SQZ-PBMC-HPV as a monotherapy is administered on Day 1 of every 3 week cycles for up to a year. In Cohort 3 (double-priming), SQZ-PBMC-HPV is also administered on Day 2 of Cycle 1. There are at least 3 groups ("Cohorts") in this Phase as follows:

* Cohort 1: specified dose SQZ-PBMC-HPV
* Cohort 2: specified dose SQZ-PBMC-HPV
* Cohort 3: specified dose SQZ-PBMC-HPV double-priming

In Part 2, SQZ-PBMC-HPV in combination with immune checkpoint inhibitors (1) atezolizumab, (2) ipilimumab, (3) nivolumab, or (4) nivolumab and ipilimumab, is administered every 3 weeks for up to a year except atezolizumab may be given up to 2 years; and ipilimumab will be administered four times (in a timeframe less than a year) if safety allows. There are 4 groups ("Cohorts") in this Phase as follows:

* Cohort 4: SQZ-PBMC-HPV RP2D (Recommended Phase 2 Dose) plus atezolizumab
* Cohort 5: SQZ-PBMC-HPV RP2D plus ipilimumab
* Cohort 6: SQZ-PBMC-HPV RP2D plus nivolumab
* Cohort 7: SQZ-PBMC-HPV RP2D plus nivolumab and ipilimumab

In Part 3, SQZ-PBMC-HPV is administered at the RP2D to patients enrolled in HPV16+ cancer-type specific cohorts. There are 4 groups ("Cohorts") in this Phase as follows:

* Cohort 8: SQZ-PBMC-HPV RP2D in HPV16+ head and neck cancer patients
* Cohort 9: SQZ-PBMC-HPV RP2D in HPV16+ cervical cancer patients
* Cohort 10: SQZ-PBMC-HPV RP2D in HPV16+ anal cancer patients
* Cohort 11: SQZ-PBMC-HPV RP2D in other HPV16+ cancer patients

antigen presenting cell therapy; therapeutic vaccine consisting of peripheral blood mononuclear cells (PBMCs) manufactured with immunogenic epitopes of HPV16

SQZ-PBMC-HPV

programmed cell death ligand 1 (PD-L1) blocking antibody

cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody

programmed cell death 1 (PD-1) blocking antibody

This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-PBMC-HPV as monotherapy and in combination with atezolizumab or other immune checkpoint inhibitors in HLA-A\*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.

Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination With Atezolizumab or Other Immune Checkpoint Inhibitors in HLA-A*02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

For SQZ-PBMC-HPV as a single agent (Part 1 and Part 3) and in combination with immune checkpoint inhibitors (Part 2)

Proportion of patients with best response of complete response \[CR\] and/or partial response \[PR\] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)

Evaluation of the BoR defined as CR, PR, Stable Disease \[SD\], Progressive Disease \[PD\] or Not Evaluable \[NE\] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)

Defined as the time from first dose of study treatment to first overall response of PD by RECIST v 1.1 or to death by any cause. This will be censored at the last RECIST v1.1 assessment if PD/death is not observed. For SQZ-PBMC-HPV as a single agent (Part 3 only)

Defined as the time from overall response of CR or PR to first overall response of PD by RECIST v1.1 or to death by any cause. This is defined only for patients who have a CR or PR and will be censored at the last RECIST v1.1 assessment if PD/Death is not observed. For SQZ-PBMC-HPV as a single agent (Part 3 only)

Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)

Defined as the time from first dose of study treatment to death by any cause. This will be censored at the last date patient is known to be alive if death is not observed. For SQZ-PBMC-HPV as a single agent (Part 3 only)

Proportion of patients with best response of complete response \[CR\] and/or partial response \[PR\] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)

Evaluation of the BoR defined as CR, PR, Stable Disease \[SD\], Progressive Disease \[PD\] or Not Evaluable \[NE\] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)

Defined as the time from first dose of study treatment to first overall response of PD by RECIST v 1.1 or to death by any cause. This will be censored at the last RECIST v1.1 assessment if PD/death is not observed. For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)

Defined as the time from overall response of CR or PR to first overall response of PD by RECIST v1.1 or to death by any cause. This is defined only for patients who have a CR or PR and will be censored at the last RECIST v1.1 assessment if PD/Death is not observed. For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)

Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)

For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)

To determine manufacturing feasibility (Part 1 only)

SQZ Biotechnologies

Participants will receive REC-4881 12mg PO dosed QD

REC-4881

Recursion Pharmacueticals

This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with unresectable locally advanced or metastatic solid tumors with AXIN1 or APC mutation.

Approximately 60 individuals will be enrolled in this open-label Phase 2 study, allocated 1:1 between the 2 cohorts - AXIN1 mutation or APC mutation. The purpose of the study is to investigate the safety, efficacy, and pharmacokinetics of REC-4881 for the treatment of participants with unresectable locally advanced or metastatic solid tumors with either mutation. Participants will receive treatment with REC-4881 (12mg PO daily) for up to 2 years.

Participants are allocated to two groups, AXIN1 mutation or APC mutation, in parallel for the duration of the study.

A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation

A Phase 2, Open Label Study of REC-4881 in Participants With Unresectable Locally Advanced or Metastatic Cancer With AXIN1 or APC Mutation

Assessment of dose limiting toxicities \[(DLTs) Safety Assessment Period only\]; Treatment emergent adverse events; Serious adverse events; Treatment discontinuation and dose modification due to toxicity

ORR according to standard RECIST 1.1 criteria

Plasma PK parameters, as appropriate, including but not limited to Cmax, Tmax, Ctrough and AUC

DCR according to standard RECIST 1.1; Duration of response (DOR), Duration of SD, and TTR

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FOG-001 in Locally Advanced or Metastatic Solid Tumors	NCT05919264	Cancer Colorectal Canc... Solid Tumor Locally Advance... Metastatic Canc... Gastric Cancer Non-small Cell ... Non-small Cell ... Non-small Cell ... Non-small Cell ... Non-Small Cell ... Gastroesophagea... WNT Pathway β-catenin Beta-catenin Adenomatous Pol... APC	FOG-001 FOG-001	18 Years -	Fog Pharmaceuticals, Inc.
Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV	NCT02403505	HPV Infection	9vHPV Vaccine p...	24 Years - 64 Years	Medicine Invention Design, Inc
Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors	NCT04084951	Adult Solid Tum...	SQZ-PBMC-HPV Atezolizumab Ipilimumab Nivolumab	18 Years -	SQZ Biotechnologies
A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation	NCT06005974	AXIN1 Gene Muta... APC Gene Mutati... Solid Tumor	REC-4881	55 Years -	Recursion Pharmaceuticals Inc.

Spots Global Cancer Trial Database for apc

Every month we try and update this database with for apc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for apc

Every month we try and update this database with for apc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for apc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.