Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants receive BL-M07D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

BL-M07D1

Hai Zhu, PHD

Sa Xiao, PHD

Rongbo Lin

Jun Jia

Ling Guan

Erwei Song

Erwei Song, PHD

Herui Yao, PHD

Hong Zong

Yahua Zhong

Jianying Huang

Meili Sun

Qing Wen

Xian Wang

In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M07D1.

In phase Ib study, the safety and tolerability of BL-M07D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.

In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-M07D1 in patients

A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of BL-M07D1injection in Patients With Locally Advanced or Metastatic HER2-positive/Low-expression Breast Cancer and Other Solid Tumors

The DLT observation period was the first treatment period for each dose level, and the DLT observation period was extended if there was a delay in administration .

In the dose escalation stage, MTD was selected as the highest dose whose DLT rate estimate was closest to the target DLT rate, but did not exceed the upper bound of the EQUIVALENT interval of DLT rate.

The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M07D1

TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B07D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1 .

Maximum serum concentration (Cmax) of BL-M07D1 will be investigated

Half-life (T1/2) of BL-M07D1 will be investigated.

AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration

Time to maximum serum concentration (Tmax) of BL-M07D1 will be investigated

CL in the serum of BL-M07D1 per unit of time will be investigated.

Ctough is defined as the lowest serum concentration of BL-M07D1 prior to the next dose will be administered.

Incidence and titer of ADA of BL-M07D1 will be evaluated.

Incidence and titer of Nab of BL-M07D1 will be evaluated

ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).

The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

The PFS is defined as the time from the participant's first dose of BL-B07D1 to the first date of either disease progression or death, whichever occurs first.

SystImmune Inc.

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Sichuan Baili Pharmaceutical Co., Ltd.

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Small Cell Lung Carcinoma

Head and Neck Neoplasms

Small Cell Lung Cancer

Participants receive BL-B01D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

BL-B01D1

Yongsheng Li

Li Zhang, PHD

Jun Yang

Zhenming Fu

Kunyu Yang

Yaqian Han

Ye Guo

Weihua Yang

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1.

In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.

In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be evaluated.

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle .

The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1

TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1 .

Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.

Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated

Half-life (T1/2) of BL-B01D1 will be investigated.

AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.

CL in the serum of BL-B01D1 per unit of time will be investigated.

Ctough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered.

Incidence and titer of ADA of BL-B01D1 will be evaluated.

Incidence and titer of Nab of BL-B01D1 will be evaluated.

The PFS is defined as the time from the participant's first dose of BL-B01D1 to the first date of either disease progression or death, whichever occurs first.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinosarcoma

Mixed Tumor, Mullerian

Ovarian Cancer

Ovarian Epithelial Cancer

Malignant Mixed Mullerian Tumor

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Rebastinib

Tubulin Modulators

Antimitotic Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Dose comparison between 50 or 100 mg BID of rebastinib orally (PO) in combination with paclitaxel administered by IV infusion at 80 mg/m2 in repeated 28-day cycles.

Dose expansion in the following tumor types at the recommended Phase 2 dose (RP2D) of rebastinib in combination with paclitaxel

* Triple-negative and Stage IV inflammatory breast cancer
* Ovarian cancer
* Endometrial cancer
* Gynecological Carcinosarcoma

rebastinib

Paclitaxel administered by IV infusion at 80 mg/m2

This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.

A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors

An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors

Measure of the time from Cycle 1 Day 1 to disease progression or death due to any cause

Measure of the time from Cycle 1 Day 1 to the first documentation of progressive disease

Measure of time from PR, CR to disease progression or death due to any cause

Deciphera Pharmaceuticals LLC

Mesothelioma

Mesothelioma, Malignant

Malignant Mesothelioma

Carboplatin

Dose comparison between 50 or 100 mg BID of rebastinib orally (PO) dosed in 21-day cycles in combination with carboplatin administered by IV infusion at either AUC5 or AUC6 once every 3 weeks

Dose expansion in the following tumor types at the recommended Phase 2 dose (RP2D) of rebastinib in combination with carboplatin

* Triple-negative breast cancer
* Platinum-sensitive Ovarian cancer
* Mesothelioma

Carboplatin administered by IV infusion at AUC5 or AUC6

This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.

A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors

An Open Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Carboplatin to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors

Measure of time from first PR, CR to disease progression or death due to any cause

Measure of the interval between Cycle 1 Day 1 until date of death from any cause

Pharmaceutical Solutions

Immune Checkpoint Inhibitors

Participants will receive dose A of ASP8374 solution intravenously on day 1 of every 3-week cycle.

Participants will receive dose B of ASP8374 solution intravenously on day 1 of every 3-week cycle.

ASP8374

Global Medical Lead

The purpose of this study is to evaluate the tolerability and safety profile and to characterize the pharmacokinetic profile of ASP8374 in Japanese patients with locally advanced (unresectable) or metastatic solid tumors.

This study also evaluates the anti-tumor effect of ASP8374.

This study consists of two arms (Arm A: ASP8374 dose A; and Arm B: ASP8374 dose B). Arm B would only be opened if Arm A is deemed tolerable.

The study consists of 2 periods: Screening (up to 28 days) and treatment period. The Dose Limiting Toxicities (DLT) observation period is set at the beginning of the treatment period. A subject can continue to participate in the study after the end of the DLT observation period until discontinuation criteria are met. After discontinuation of study drug treatment, all subjects will complete an end of treatment visit and safety follow-up visits.

Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors

A Phase 1, Open Label Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

DLT is graded using National Cancer Institute Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\] Version 4.03. The DLT observation period may be increased if deemed appropriate by the Tolerability Evaluation Meeting.

An AE is any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.

Most frequent immune-related AEs observed with currently approved checkpoint inhibitors include rash, oral mucositis, dry mouth, colitis/diarrhea, hepatitis, pneumonitis, and endocrinopathies .

An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, life-threatening, persistent or significant disability/incapacity or substantial disruption, congenital anomaly or birth defect, hospitalization, or medically important event

Number of patients with potentially clinically significant laboratory values.

ECGs should be obtained after the subject has rested quietly and is awake in a fully supine position (or semi-recumbent, if supine is not tolerated) for 10 minutes before the first ECG from a triplicate or single ECG. Any clinically significant adverse changes on the ECS will be reported as (serious) AEs.

Number of patients with potentially clinically significant vital sign values.

Number of patients with potentially clinically significant physical exam values.

The ECOG Scale \[Oken, 1982\] will be used to assess performance status ; 0=Fully active, able to carry on all predisease performance without restriction; 1=Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, (e.g., light housework, office work); 2=Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

AUClast: area under the concentration-time curve from the time of dosing up to the last measurable concentration. AUClast will be derived from the PK serum samples collected.

AUCinf: AUC from the time of dosing extrapolated to time infinity. AUCinf will be derived from the PK serum samples collected.

AUCinf(%extrap): Percentage of AUCinf due to extrapolation from the last measurable concentration to time infinity

AUCtau: AUC from the time of dosing to the start of the next dosing interval at multiple dose conditions. AUCtau will be derived from the PK serum samples collected.

Cmax: maximum concentration. Cmax will be derived from the PK serum samples collected.

Ctrough: trough concentration. Ctrough will be derived from the PK serum samples collected.

tmax: time of maximum concentration. Tmax will be derived from the PK serum samples collected.

t1/2: terminal elimination half-life. t1/2 will be derived from the PK serum samples collected.

tlast: time of last measurable concentration. tlast will be derived from the PK serum samples collected.

CL: total clearance after intravenous dosing. CL will be derived from the PK serum samples collected.

Vz: volume of distribution after intravenous dosing during the terminal elimination phase. will be derived from the PK serum samples collected. Vz will be derived from the PK serum samples collected.

Vss: volume of distribution at steady state after intravenous dosing. Vss will be derived from the PK serum samples collected.

Tumor size is defined as the sum of the diameters of all target lesions per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percent change from baseline in tumor size will be calculated for subjects with target lesions at baseline.

BOR is defined as the best response recorded from the start of the study treatment until the end of treatment.

Astellas Pharma Inc

Mitogens

Dose escalation:

The starting dose of the combination will be escalated in a stepwise fashion, escalating one drug at a time.

Dose expansion (urothelial cancer):

Patients in the dose expansion will be treated with the combination identified in the dose escalation part of the study.

Dose escalation:

Starting dose is rogaratinib 400 mg twice daily (b.i.d.) in continuous 28-day cycles from Cycle 1 Day 3 onwards.

Dose expansion:

With dose identified in dose escalation part.

Rogaratinib (BAY1163877)

Dose escalation:

Starting dose is 45 mg on Days 1, 8 and 15 of each 28-day cycle.

Dose expansion:

With dose identified in dose escalation part.

Copanlisib (BAY80-6946)

The primary objective of this study is to determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) and efficacy of rogaratinib in combination with copanlisib in patients with locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype.

The secondary objectives of this study are to characterize the pharmacokinetics (PK) of rogaratinib and copanlisib alone and in combination, and to assess the anti-tumor efficacy of rogaratinib in combination with copanlisib for locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype.

Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors

A Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the Combination of Rogaratinib and Copanlisib in Patients With FGFR-positive, Locally Advanced or Metastatic Solid Tumors

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

ORR in patients receiving the recommended dose of the rogaratinib-copanlisib-combination during the dose expansion part

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors	NCT05461768	Breast Cancer Locally Advance...	BL-M07D1	18 Years - 75 Years	Sichuan Baili Pharmaceutical Co., Ltd.
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor	NCT05194982	Locally Advance...	BL-B01D1	18 Years - 75 Years	Sichuan Baili Pharmaceutical Co., Ltd.
A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors	NCT03601897	Locally Advance...	rebastinib Paclitaxel	18 Years -	Deciphera Pharmaceuticals LLC
A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors	NCT03717415	Locally Advance...	rebastinib Carboplatin	18 Years -	Deciphera Pharmaceuticals LLC
Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors	NCT03945253	Advanced Solid ...	ASP8374	20 Years -	Astellas Pharma Inc
A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors	NCT03601897	Locally Advance...	rebastinib Paclitaxel	18 Years -	Deciphera Pharmaceuticals LLC
Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors	NCT03945253	Advanced Solid ...	ASP8374	20 Years -	Astellas Pharma Inc
Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors	NCT03517956	Advanced or Met...	Rogaratinib (BA... Copanlisib (BAY...	18 Years -	Bayer

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