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130 active trials for Advanced Solid Tumors

Study to Evaluate CCS1477 in Advanced Tumours

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with metastatic castration resistant prostate cancer (mCRPC) or advanced solid tumours.

Start: July 2018

First-in-human Study of Oral TP-0903 (a Novel Inhibitor of AXL Kinase) in Patients With Advanced Solid Tumors

TP-0903 is a novel oral inhibitor that targets AXL kinase and reverses the mesenchymal phenotype associated with advanced cancers. Preclinical studies have shown promising antitumor activity of TP-0903 as a single agent against a variety of tumor types in both in vitro and in vivo studies. This first-in-human Phase 1a study is conducted to identify the maximum tolerated dose (MTD) of TP-0903 administered orally to patients with advanced solid tumors and to identify the safety profile and Recommended Phase 2 Dose (RP2D) of TP-0903. Once the MTD has been established, additional patients with specific tumor types (advanced solid tumors that have progressed after achieving a best documented response of at least stable disease (ie, SD, PR, or CR documented per iRECIST following at least 2 cycles (8 weeks) of immunotherapy, EGFR+ Non Small Cell Lung Cancer [NSCLC] and have demonstrated recent progression following a best documented response of at least stable disease (ie, SD, PR, or CR documented per RECIST v1.1 on ?2 lines of oral TKIs (Prior chemotherapy ± immunotherapy is allowed as long as the patient is clearly demonstrating current progression on an EGFR TKI.), BRAF-, KRAS-, or NRAS-mutated Colorectal Carcinoma [CRC] for whom there is no standard therapy remaining, persistent/recurrent Ovarian Cancer who would be platinum refractory/ resistant and have had any number of lines of prior therapy, and BRAF-mutated Melanoma that has not responded to immunotherapy or a combination BRAF/MEK inhibitor) will be enrolled at the MTD in the Phase 1b study. Data collected from patients enrolled in each of these additional cohorts will be used for to confirm safety, explore potential biomarkers, and evaluate potential signals of activity when TP-0903 is administered to specific groups of heavily pretreated patients or given in combination with immunotherapy or a tyrosine kinase inhibitor (TKI). The study will investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity profiles.

Start: December 2016

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

Start: July 2020

IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors

This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced solid tumors.

Start: September 2018

TLD-1, a Novel Liposomal Doxorubicin, in Patients With Advanced Solid Tumors

TLD-1 is a novel liposomal formulation of doxorubicin (PEG surface) that compared favorably to conventional liposomal formulations of doxorubicin including Caelyx® in preclinical in vivo models. Particle features including size, charge distribution, lipid composition and drug release add up to a considerably altered particle behavior compared to Caelyx®, potentially explaining the lack of hand-foot-syndrome in respective animal models. Preclinical evaluation confirmed TLD-1 to be a promising new and innovative formulation of doxorubicin with promising activity and good tolerability.

Start: November 2018

This is a Study to Evaluate the Safety and Tolerability of the Study Drug ABL001, and to Determine the Maximum Tolerated Dose and/or Recommended Phase 2 Study Dose of ABL001

The purpose of this open-label, dose escalation-dose expansion, Phase 1 clinical trial is to evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of NOV1501 (ABL001).

Start: September 2017

The Effect of Tesetaxel on the QTc Interval and the Effect of Food, Itraconazole, and Rifampin on Tesetaxel Pharmacokinetics in Patients With Advanced Solid Tumors

This is a 3-cohort, multicenter, Phase 1 study of the effect of tesetaxel, an investigational, orally administered taxane, on the corrected QT (QTc) interval and the potential effect of food, a cytochrome P450 (CYP) 3A inhibitor (itraconazole), and a CYP3A inducer (rifampin) on tesetaxel pharmacokinetics (PK) in adult patients with advanced solid tumors.

Start: March 2020

FGFR4 Inhibitor EVER4010001 in Combination With PD-1 Inhibitor Pembrolizumab in Patients With Advanced Solid Tumors

The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of EVER4010001 in combination with Pembrolizumab in Patients with Advanced Solid Tumors. And in phase II to assess the anti-tumor efficacy of EVER4010001 in combination with Pembrolizumab in treating selected indications using appropriate biomarkers.

Start: July 2020

A Study of ION537 in Patients With Molecularly Selected Advanced Solid Tumors

The purpose of this study is to evaluate the safety and establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ION537 when administered by intravenous infusion in patients with advanced solid tumors.

Start: January 2021

Evaluation of the Safety and Efficacy of Albumin-bound Docetaxel

This trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of albumin-bound formulation of docetaxel for intravenous infusion in patients with advanced solid tumors.

Start: December 2020

Evaluation of the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors

Based on the overwhelming positive response to this survey and the large number of patients being treated with PD-1/PD-L1 therapy in the UPMC system, the investigators are proposing a trial that will randomize patients who have disease stability to stop treatment at 1 year or continue treatment until disease progression. The investigators anticipate that the results of this study will answer questions regarding the optimal duration of treatment. therapy.

Start: November 2019

A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.

Start: September 2020

A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors

TQB2618 is a TIM-3 receptor monoclonal antibody that binds to the extracellular domain of TIM-3 outside the cell to block the binding of TIM-3 to its ligand, thereby inhibiting the downstream signal transduction of TIM-3 and deactivating TIM-3 Inhibition of immune cells. The purpose of this study was to evaluate the safety, tolerability, pharmacokinetic parameters and antitumor effects of TQB2618 injection in subjects with advanced solid tumors.

Start: December 2020

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in subjects with advanced solid tumors.

Start: February 2019

M8891 First in Human in Solid Tumors

The purpose of this study is to determine the maximum tolerated dose (MTD), safety, tolerability, Pharmacokinetic (PK), pharmacodynamic and clinical activity of M8891 as single agent in participants with advanced solid tumors in Part 1 and to determine the safety, tolerability, PK and antitumor activity of M8891 combined with cabozantinib in participants with metastatic renal cell carcinoma (mRCC) in Part 2 (Part 2a and Part 2b) of the study.

Start: August 2017

Trial of ZN-A-1041 Enteric Capsules in Patients With HER2-Positive Advanced Solid Tumors

This will be a phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination with Capecitabine in patients with HER2-positive advanced solid tumors with or without brain metastases. The study will consist of three phases: phase 1a (dose escalation with ZN-A-1041 monotherapy), phase 1b (dose escalation with ZN-A-1041 and Capecitabine combination therapy) and phase 1c (dose expansion with ZN-A-1041 and Capecitabine combination therapy).

Start: October 2020

A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics). The Dose Escalation Phase and is no longer enrolling. The Dose Expansion Phase currently has two cohorts: one for the study of PT-112 in patients with thymoma and thymic carcinoma, and the second in the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC). Condition or disease: Advanced Solid Tumors; Thymoma and Thymic Carcinoma; Metastatic Castrate Resistant Prostate Cancer (mCRPC) Intervention/treatment: Drug: PT-112 Injection Phase: Phase 1/2

Start: July 2014

MTD, Safety and Efficacy of NYH817G and NYH100P in Monotherapy and Combination in Patients With Advanced Solid Tumors

The objectives of this study are: Part 1: To assess the MTD, safety and efficacy of each NYH817G and NYH100P in monotherapy in patients with advanced solid tumors who have failed approved standard therapies. To assess the PK properties and the preliminary effectiveness of monotherapy of NYH817G and NYH100P. Part 2: To assess the MTD, RP2D, safety and efficacy of NYH817G and NYH100P in combination therapy in patients with advanced solid tumors who have failed approved standard therapies To assess the PK properties, the preliminary effectiveness and the changes in metabolism of combination therapy of NYH817G and NYH100P.

Start: December 2019

Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors.

The therapeutic approach taken by trial SAKK 66/17 is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy. Patients with laser ablation-accessible solid tumors are treated by thermal ablation followed immediately by an intratumoral injection of IP-001 (1 % N-dihydro-galacto-chitosan, Immunophotonics Inc.) for injection). IP-001 is intended to trigger a tumor-specific systemic immune response when exposed to tumor antigens liberated by thermal ablation. There is strong preclinical and early clinical evidence that combining thermal ablation with IP-001 might be able to turn 'cold' tumors into 'hot' tumors, inducing a systemic immune response. This may result in shrinkage of the treated tumor, as well as, long-term response mediated by the patient's immunological defense system against any remaining tumor cells (residual primary and metastatic tumor cells) including tumor cells outside or distant from the treated area (also known as abscopal effect). This trial will provide information on the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in patients with laser ablation-accessible solid tumors ('all comers', Part 1 - safety run in). Further information on safety and tolerability, as well as preliminary antitumor activity, will be evaluated in patients with soft tissue sarcoma (Part 2, Cohort1), whereas in melanoma patients, anti-tumor activity will be defined as a primary objective (Part 2, Cohort 2). The trial treatment consists of an Ablation + IP-001 in 4-week intervals for up to 6 scheduled treatments. Thermal ablation will be performed according to the instruction of the medical device, and IP-001 will be administered in different dose levels according to the trial design. All patients will be followed until progression of disease or until the start of a subsequent treatment.

Start: October 2020

A Study of OKI-179 in Patients With Solid Tumors

This study is a Phase 1, single center, open-label study, assessing single agent dose escalation of OKI-179.

Start: May 2019