Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Paclitaxel

Albumin-Bound Paclitaxel

Dactolisib

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

BEZ235 + paclitaxel

BKM120 + paclitaxel

BEZ235 + paclitaxel + trastuzumab

BKM120 + paclitaxel + trastuzumab

Novartis Pharmaceuticals

The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.

A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab

A Phase Ib Multi-center, Open-label, 4-arm Dose-escalation Study of Oral BEZ235 and BKM120 in Combination With Weekly Paclitaxel in Patients With Advanced Solid Tumors and Weekly Paclitaxel/Trastuzumab in Patients With HER2+ Metastatic Breast Cancer

Rare Diseases

Camurati-Engelmann Disease

Antibodies

Antibodies, Bispecific

Immunoglobulins

Y101D in subjects with Metastatic or Locally Advanced Solid Tumors

Cohort 1 of Y101D

Cohort 2 of Y101D

Y101D, 10mg/kg, Q2W, intravenous infusion

Cohort 3 of Y101D

Y101D, 20mg/kg, Q2W, intravenous infusion

Cohort 4 of Y101D

Y101D, 30mg/kg, Q2W, intravenous infusion

Cohort 5 of Y101D

Li Zhang, MD

This is a phase 1, multicenter, open-label study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of Y101D in patients with metastatic or locally advanced solid tumors.

This study will consist of two parts: dose escalation part and cohort expansion part.

In dose escalation part, up to 5 dose-escalation cohorts will be sequentially enrolled in this study. The five dose levels are 1, 3, 10, 20 and 30 mg/kg. DLTs will be evaluated during the first treatment cycle, which is 28 days. The study consists of a 4-week screening period, a 4-week core treatment period for DLT evaluation, a treatment extension period, a safety follow-up visit for approximately 30 days following the last dose of Y101D, and survival follow-ups every 3 months thereafter.

In cohort expansion part, To further characterize safety and efficacy of Y101D, cohort expansion will be allowed in the following two circumstances: MTD cohort expansion if the MTD could be identified; Benefited dose cohort if it could be determined by Investigator.

A Trial of Y101D, a PD-L1/TGF-β Bispecific Antibody, in Patients With Metastatic or Locally Advanced Solid Tumors

A Phase 1, Multicenter, Open-label, Dose-increasing Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of Y101D, a Recombinant Anti-PD-L1 and TGF-β Bispecific Antibody for Injection, in Patients With Metastatic or Locally Advanced Solid Tumors

DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

The presence of antibodies directed against the biotherapeutic medicine upon administration, including the ADA and Nab.

ORR is defined as percentage of participants who achieved complete response (CR), partial response (PR), based on RESIST 1.1.

TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression.

Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in RESIST 1.1.

PFS was defined as the time between the date of first dose of Y101 and either disease progression or death, whichever occurs first.

OS was defined as the number of days from administration of the first infusion (Day 1) to date of death.

Time to first response was defined as the time from the date of first dose of Y101 to the date of initial documentation of a response (PR or better).

Wuhan YZY Biopharma Co., Ltd.

Anti-Infective Agents

Everolimus

Sorafenib

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Everolimus run-in period followed by continuous administration of everolimus and sorafenib

Sorafenib run-in period followed by continuous administration of everolimus and sorafenib

Continuous administration of everolimus and intermittent administration of sorafenib

Everolimus will be given alone during a 2 week run-in period before starting sorafenib. Subsequently sorafenib will be administered twice a day while everolimus will be given once a day continuously.

Everolimus and sorafenib

Sorafenib will be given alone during a 2 week run-in period before starting everolimus. Subsequently sorafenib will be administered twice a day while everolimus will be given once a day continuously.

Bid sorafenib will be given every other week alternating with 1 week qd everolimus. Doses will be escalated.

Sorafenib will be given twice a day for 3 days-on 4 days-off while everolimus will be administered continuously on a daily basis. Doses will be escalated.

BENOIT YOU, MD PhD

CATHERINE BARROIS

EVESOR multiparameter phase I trial aims at determining the safety of different doses and dosing schedules of everolimus in combination with sorafenib as well as the recommended doses \& dosing schedules for phase 2 trials in adult patients with advanced solid tumors.

The present phase I trial aims at determining the safety of different doses and dosing schedules of everolimus in combination with sorafenib as well as the recommended doses \& dosing schedules for phase 2 trials in adult patients with advanced solid tumors.

EVESOR: a Phase 1 Trial of Everolimus and Sorafenib

EVESOR: a Phase 1 Trial of Everolimus and Sorafenib to Assess the Impact of Doses and Administration Sequences on Pharmacokinetic and Pharmacodynamic Effects of the Combination

Preliminary antitumor activity of everolimus-sorafenib combination

Pharmacodynamic (PD) effects of everolimus in combination with sorafenib on PI3K-AKT-mTor and RAS-RAF-ERK signaling pathways in tumor and surrogate tissues

Relationships between PK and PD effects measured in tumor and surrogate tissues

Hospices Civils de Lyon

Subjects will receive an intravenous infusion of SHR-1701 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

SHR-1701

Linna Wang, MD

Lin Shen, MD

The main purpose of this Phase I study is to access the safety and tolerability of SHR-1701 at different dose levels. It is hoped to find out the recommended dose for Phase II/III.

This is a Phase I, open-label trial in patients with metastatic or locally advanced solid tumor. There are three parts of the study: a dose-escalation part, a dose-expansion part, and a clinical expansion part. Dose escalation part is a standard "3+3" cohort design, for which 3 or 6 subjects will be enrolled at each dose level depending on the occurrence of dose-limiting toxicities (DLTs). Dose-expansion means that at least 10 subjects (included subjects of the dose-escalation part) will be selected in 2 - 3 dose levels to focus on the pharmacokinetics (PK) / pharmacodynamic (PD) features. After determination of the recommended dose for Phase II (RP2D), clinical expansion will be opened. Many more subjects will be invited to take part in the study and received the study drug at the RP2D. Additional purpose of the study is to find out whether the study drug has anti-tumor effects.

SHR-1701 in Metastatic or Locally Advanced Solid Tumors

A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

Number of Subjects who occurs dose-limiting toxicity (DLTs)

ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ¡Ý30% decrease in the sum of diameters of target lesions) per RECIST 1.1.

DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.

Jiangsu HengRui Medicine Co., Ltd.

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Dexamethasone acetate

To identify the maximally tolerated dose (MTD) of PEGPH20.

PEGylated Recombinant Human Hyaluronidase

PEGPH20

Joy Zhu, M.D.

This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.

A study of PEGylated recombinant human hyaluronidase (PEGPH20) administered on a twice weekly schedule for 28 days followed by a weekly dosing schedule in patients with advanced solid tumors who have either failed to respond to standard therapy or for whom no standard therapy exists.

Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors

A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors

The PEGPH20 monotherapy MTD is the highest dose at which no more than one of six evaluable patients experience Dose-Limiting Toxicity (DLT)

All safety data will be evaluated using the NCI CTCAE scoring system (version 4.0)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab	NCT01285466	Metastatic or L...	BEZ235 + paclit... BKM120 + paclit... BEZ235 + paclit... BKM120 + paclit...	18 Years -	Novartis
A Trial of Y101D, a PD-L1/TGF-β Bispecific Antibody, in Patients With Metastatic or Locally Advanced Solid Tumors	NCT05028556	Metastatic or L...	Cohort 1 of Y10... Cohort 2 of Y10... Cohort 3 of Y10... Cohort 4 of Y10... Cohort 5 of Y10...	18 Years - 75 Years	Wuhan YZY Biopharma Co., Ltd.
EVESOR: a Phase 1 Trial of Everolimus and Sorafenib	NCT01932177	Metastatic or L...	Everolimus and ... Everolimus and ... Everolimus and ... Everolimus and ...	18 Years -	Hospices Civils de Lyon
SHR-1701 in Metastatic or Locally Advanced Solid Tumors	NCT03710265	Solid Tumor	SHR-1701	18 Years - 75 Years	Jiangsu HengRui Medicine Co., Ltd.
A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab	NCT01285466	Metastatic or L...	BEZ235 + paclit... BKM120 + paclit... BEZ235 + paclit... BKM120 + paclit...	18 Years -	Novartis
Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors	NCT01170897	Solid Tumor	PEGPH20	18 Years -	Halozyme Therapeutics

Spots Global Cancer Trial Database for metastatic or locally advanced solid tumors